🔍 RecallPedia

Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous introduction of devices into the radial artery for diagnostic and therapeutic purposes.

Class I - Dangerous
🏥 Medical Devices Recalled: October 9, 2013 Arrow International Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Multiple: Expressed as Catalog # (AA#) lot number (RF#), and expiration date (year-month) : AA-15611-S RF0018142 2015-01 AA-15611-S RF1069509 2016-06 AA-15511-S RF0021262 2015-02 AA-15611-S RF1069978 2016-06 AA-15611-S RF0021263 2015-03 AA-15611-S RF1070556 2016-07 AA-15511-S RF0022395 2015-03, AA-15611-S RF1070730 2016-07, AA-15611-S RF0022652 2015-03, AA-15511-S RF1070880 2016-07, AA-15511-S RF0033719 2015-03, AA-15611-S RF1071062 2016-07, AA-15511-S RF0046459 2015-04, AA-15611-S RF1071206 2016-08, AA-15611-S RF0046461 2015-04, AA-15511-S RF1071354 2016-07, AA-15611-S RF0048269 2015-05, AA-15611-S RF1071757 2016-08, AA-15511-S RF0059652 2015-06, AA-15511-S RF1071798 2016-08, AA-15511-S RF0062416 2015-06, AA-15611-S RF1082042 2016-08, AA-15611-S RF0062419 2015-06, AA-15611-S RF1082374 2016-08, AA-15611-S RF0087575 2015-08, AA-15611-S RF1082709 2016-08, AA-15511-S RF0087577 2015-08, AA-15611-S RF1082956 2016-08, AA-15611-S RF0087845 2015-08, AA-15511-S RF1082959 2016-08, AA-15511-S RF0088503 2015-08, AA-15511-S RF1083632 2016-09, AA-15611-S RF0089041 2015-08, AA-10407-1 RF1093923 2013-09, AA-15511-S RF0091088 2015-09, AA-10507-1 RF1093924 2013-09, AA-15611-S RF0092014 2015-09, AA-10511-1 RF1093925 2013-09, AA-15511-S RF0092144 2015-09, AA-15511-S RF1093936 2016-09, AA-15511-S RF0104465 2015-10, AA-15611-S RF1093937 2016-09, AA-15611-S RF0104466 2015-10, AA-15611-S RF1094515 2016-10, AA-15611-S RF0115587 2015-11, AA-15511-S RF1094910 2016-10, AA-15511-S RF0115903 2015-11, AA-15611-S RF1105690 2016-10, AA-15611-S RF0117454 2015-12, AA-15611-S RF1105980 2016-10, AA-15511-S RF0117682 2015-12, AA-15511-S RF1105983 2016-10, AA-15611-S RF0129193 2016-01, AA-15511-S RF1106517 2016-11, AA-15611-S RF1010343 2016-01, AA-15611-S RF1117682 2016-11, AA-15611-S RF1011171 2016-01, AA-15611-S RF1128383 2016-12, AA-15511-S RF1011172 2016-01, AA-15511-S RF2010359 2017-01, AA-15511-S RF1019756 2016-01, AA-15611-S RF2010467 2017-02, AA-15511-S RF1022056 2016-02, AA-15511-S RF2010675 2017-02, AA-15611-S RF1023132 2016-03, AA-15611-S RF2010868 2017-02, AA-15611-S RF1033969 2016-03, AA-15611-S RF2019197 2017-01, AA-15611-S RF1034279 2016-03, AA-15511-S RF2019230 2017-01, AA-15611-S RF1035009 2016-04, AA-15611-S RF2019759 2017-01, AA-15511-S RF1035112 2016-04, AA-15511-S RF2021565 2017-03, AA-15611-S RF1045491 2016-04, AA-15611-S RF2021612 2017-03, AA-15511-S RF1045951 2016-04, AA-15611-S RF2022115 2017-03, AA-15611-S RF1046643 2016-05, AA-15611-S RF2022510 2017-03, AA-15611-S RF1046962 2016-05, AA-15611-S RF2033301 2017-03, AA-15511-S RF1057481 2016-05, AA-15511-S RF2033341 2017-03, AA-15511-S RF1060013 2016-07, AA-15611-S RF2033811 2017-03, AA-15611-S RF1060349 2016-07, AA-15611-S RF2044703 2017-04, AA-15611-S RF1068720 2016-06, AA-15511-S RF2044756 2017-04, AA-15511-S RF1069507 2016-06, AA-15611-S RF2045176 2017-04, AA-15511-S RF2045508 2017-05, AA-10607-1 RF2107371 2014-10, AA-15611-S RF2045513 2017-04, AA-15511-3 RF2107374 2014-10, AA-15611-S RF2046241 2017-05, AA-10507-1 RF2107659 2014-10, AA-15611-S RF2056688 2017-05, AA-10507-1 RF2108238 2014-10, AA-10407-1 RF2056874 2014-05, AA-15511-3 RF2108239 2014-10, AA-10407-1 RF2057003 2014-05, AA-15511-S RF2108240 2017-10, AA-15611-S RF2057702 2017-05, AA-15611-3 RF2108243 2014-10, AA-15611-S RF2058443 2017-06, AA-10511-1 RF2108519 2014-10, AA-15611-S RF2058727 2017-06, AA-10524-1 RF2108830 2014-11, AA-15611-S RF2060013 2017-06, AA-10611-1 RF2109094 2014-11, AA-15611-S RF2060748 2017-07, AA-10507-1 RF2110742 2015-01, AA-15611-S RF2069110 2017-06, AA-10607-1 RF2111224 2015-01, AA-15511-S RF2071172 2017-07, AA-15511-S RF2119659 2017-11, AA-15611-S RF2071228 2017-07, AA-10611-1 RF3013490 2015-01, AA-10611-1 RF2071405 2014-07, AA-15511-S RF8095418 2013-09, AA-10624-1 RF2071406 2014-07, AA-15611-S RF8095420 2013-09, AA-10511-1 RF2071407 2014-07, AA-15511-S RF8095817 2013-09, AA-10507-1 RF2071408 2014-07, AA-15611-S RF8096588 2013-09, AA-10607-1 RF2071409 2014-07, AA-15511-S RF8097142 2013-10, AA-10507-1 RF2071428 2014-07, AA-15611-S RF8097143 2013-10, AA-15511-S RF2071836 2017-07, AA-15611-S RF8108474 2013-10, AA-15511-S RF2072114 2017-08, AA-15511-S RF8109405 2013-10, AA-15611-S RF2072265 2017-07, AA-15611-S RF8110519 2013-11, AA-10407-1 RF2072322 2014-08, AA-15611-S RF8111258 2013-11, AA-10511-1 RF2072700 2014-08, AA-15511-S RF8119837 2013-11, AA-10507-1 RF2082733 2014-08, AA-15611-S RF8119838 2013-11, AA-10607-1 RF2082876 2014-08, AA-15511-S RF8122732 2013-12, AA-10507-1 RF2083221 2014-08, AA-15611-S RF8122734 2013-12, AA-15511-S RF2083300 2017-08, AA-15511-S RF9014645 2014-01, AA-10624-1 RF2083454 2014-08, AA-15611-S RF9014646 2014-01, AA-10511-1 RF2083574 2014-08, AA-15511-S RF9027936 2014-02, AA-10611-1 RF2083576 2014-08, AA-15611-S RF9027938 2014-02, AA-10624-1 RF2083577 2014-08, AA-15511-S RF9030868 2014-04, AA-10507-1 RF2083578 2014-08, AA-15611-S RF9030870 2014-04, AA-15611-S RF2083790 2017-08, AA-15511-S RF9043881 2014-05, AA-10607-1 RF2083917 2014-08, AA-15611-S RF9056723 2014-06, AA-15611-S RF2084674 2017-09, AA-15511-S RF9057834 2014-06, AA-10611-1 RF2084732 2014-09, AA-15611-S RF9069105 2014-07, AA-15511-S RF2084734 2017-09, AA-15611-S RF9070830 2014-08, AA-10511-1 RF2095165 2014-09, AA-15511-S RF9073033 2014-08, AA-10611-1 RF2096244 2014-09, AA-15611-S RF9085114 2014-08, AA-10611-1 RF2096785 2014-10, AA-15511-S RF9085142 2014-08, AA-15611-S RF9085720 2014-09, AA-15611-S RF9086531 2014-09, AA-15611-S RF9100255 2014-10, AA-15511-S RF9101704 2014-11, AA-15511-S RF9109533 2014-10, AA-15611-S RF9112368 2014-11, AA-15611-S RF9114142 2014-11, AA-15511-S RF9114143 2014-11, AA-15611-S RF9127372 2015-01, AA-15511-S RF9127374 2015-01, AA-15611-S RV0018374 2015-01, AA-15611-S RV0018375 2015-01, AA-15611-S RV0018376 2015-01, AA-15611-S RV0018927 2015-01, AA-10507-1 RV2069822 2014-06, AA-10607-1 RV2069823 2014-06, AA-10511-1 RV2069824 2014-06, AA-10611-1 RV2069826 2014-06, AA-10624-1 RV2069827 2014-06, AA-15511-3 RV2095275 2014-09, AA-15611-3 RV2095276 2014-09, AA-15611-3 RV2096130 2014-09, AA-15511-3 RV2096154 2014-09, AA-10411-1 RV2096427 2014-09, AA-10524-1 RV2096435 2014-09.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Arrow International Inc
Reason for Recall:
There is a risk that the introducer needles packaged within the kits can be partially or fully occluded, which can cause delayed treatment or an adverse event when used on a patient.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous introduction of devices into the radial artery for diagnostic and therapeutic purposes.

Product Codes/Lot Numbers:

Multiple: Expressed as Catalog # (AA#) lot number (RF#), and expiration date (year-month) : AA-15611-S RF0018142 2015-01 AA-15611-S RF1069509 2016-06 AA-15511-S RF0021262 2015-02 AA-15611-S RF1069978 2016-06 AA-15611-S RF0021263 2015-03 AA-15611-S RF1070556 2016-07 AA-15511-S RF0022395 2015-03, AA-15611-S RF1070730 2016-07, AA-15611-S RF0022652 2015-03, AA-15511-S RF1070880 2016-07, AA-15511-S RF0033719 2015-03, AA-15611-S RF1071062 2016-07, AA-15511-S RF0046459 2015-04, AA-15611-S RF1071206 2016-08, AA-15611-S RF0046461 2015-04, AA-15511-S RF1071354 2016-07, AA-15611-S RF0048269 2015-05, AA-15611-S RF1071757 2016-08, AA-15511-S RF0059652 2015-06, AA-15511-S RF1071798 2016-08, AA-15511-S RF0062416 2015-06, AA-15611-S RF1082042 2016-08, AA-15611-S RF0062419 2015-06, AA-15611-S RF1082374 2016-08, AA-15611-S RF0087575 2015-08, AA-15611-S RF1082709 2016-08, AA-15511-S RF0087577 2015-08, AA-15611-S RF1082956 2016-08, AA-15611-S RF0087845 2015-08, AA-15511-S RF1082959 2016-08, AA-15511-S RF0088503 2015-08, AA-15511-S RF1083632 2016-09, AA-15611-S RF0089041 2015-08, AA-10407-1 RF1093923 2013-09, AA-15511-S RF0091088 2015-09, AA-10507-1 RF1093924 2013-09, AA-15611-S RF0092014 2015-09, AA-10511-1 RF1093925 2013-09, AA-15511-S RF0092144 2015-09, AA-15511-S RF1093936 2016-09, AA-15511-S RF0104465 2015-10, AA-15611-S RF1093937 2016-09, AA-15611-S RF0104466 2015-10, AA-15611-S RF1094515 2016-10, AA-15611-S RF0115587 2015-11, AA-15511-S RF1094910 2016-10, AA-15511-S RF0115903 2015-11, AA-15611-S RF1105690 2016-10, AA-15611-S RF0117454 2015-12, AA-15611-S RF1105980 2016-10, AA-15511-S RF0117682 2015-12, AA-15511-S RF1105983 2016-10, AA-15611-S RF0129193 2016-01, AA-15511-S RF1106517 2016-11, AA-15611-S RF1010343 2016-01, AA-15611-S RF1117682 2016-11, AA-15611-S RF1011171 2016-01, AA-15611-S RF1128383 2016-12, AA-15511-S RF1011172 2016-01, AA-15511-S RF2010359 2017-01, AA-15511-S RF1019756 2016-01, AA-15611-S RF2010467 2017-02, AA-15511-S RF1022056 2016-02, AA-15511-S RF2010675 2017-02, AA-15611-S RF1023132 2016-03, AA-15611-S RF2010868 2017-02, AA-15611-S RF1033969 2016-03, AA-15611-S RF2019197 2017-01, AA-15611-S RF1034279 2016-03, AA-15511-S RF2019230 2017-01, AA-15611-S RF1035009 2016-04, AA-15611-S RF2019759 2017-01, AA-15511-S RF1035112 2016-04, AA-15511-S RF2021565 2017-03, AA-15611-S RF1045491 2016-04, AA-15611-S RF2021612 2017-03, AA-15511-S RF1045951 2016-04, AA-15611-S RF2022115 2017-03, AA-15611-S RF1046643 2016-05, AA-15611-S RF2022510 2017-03, AA-15611-S RF1046962 2016-05, AA-15611-S RF2033301 2017-03, AA-15511-S RF1057481 2016-05, AA-15511-S RF2033341 2017-03, AA-15511-S RF1060013 2016-07, AA-15611-S RF2033811 2017-03, AA-15611-S RF1060349 2016-07, AA-15611-S RF2044703 2017-04, AA-15611-S RF1068720 2016-06, AA-15511-S RF2044756 2017-04, AA-15511-S RF1069507 2016-06, AA-15611-S RF2045176 2017-04, AA-15511-S RF2045508 2017-05, AA-10607-1 RF2107371 2014-10, AA-15611-S RF2045513 2017-04, AA-15511-3 RF2107374 2014-10, AA-15611-S RF2046241 2017-05, AA-10507-1 RF2107659 2014-10, AA-15611-S RF2056688 2017-05, AA-10507-1 RF2108238 2014-10, AA-10407-1 RF2056874 2014-05, AA-15511-3 RF2108239 2014-10, AA-10407-1 RF2057003 2014-05, AA-15511-S RF2108240 2017-10, AA-15611-S RF2057702 2017-05, AA-15611-3 RF2108243 2014-10, AA-15611-S RF2058443 2017-06, AA-10511-1 RF2108519 2014-10, AA-15611-S RF2058727 2017-06, AA-10524-1 RF2108830 2014-11, AA-15611-S RF2060013 2017-06, AA-10611-1 RF2109094 2014-11, AA-15611-S RF2060748 2017-07, AA-10507-1 RF2110742 2015-01, AA-15611-S RF2069110 2017-06, AA-10607-1 RF2111224 2015-01, AA-15511-S RF2071172 2017-07, AA-15511-S RF2119659 2017-11, AA-15611-S RF2071228 2017-07, AA-10611-1 RF3013490 2015-01, AA-10611-1 RF2071405 2014-07, AA-15511-S RF8095418 2013-09, AA-10624-1 RF2071406 2014-07, AA-15611-S RF8095420 2013-09, AA-10511-1 RF2071407 2014-07, AA-15511-S RF8095817 2013-09, AA-10507-1 RF2071408 2014-07, AA-15611-S RF8096588 2013-09, AA-10607-1 RF2071409 2014-07, AA-15511-S RF8097142 2013-10, AA-10507-1 RF2071428 2014-07, AA-15611-S RF8097143 2013-10, AA-15511-S RF2071836 2017-07, AA-15611-S RF8108474 2013-10, AA-15511-S RF2072114 2017-08, AA-15511-S RF8109405 2013-10, AA-15611-S RF2072265 2017-07, AA-15611-S RF8110519 2013-11, AA-10407-1 RF2072322 2014-08, AA-15611-S RF8111258 2013-11, AA-10511-1 RF2072700 2014-08, AA-15511-S RF8119837 2013-11, AA-10507-1 RF2082733 2014-08, AA-15611-S RF8119838 2013-11, AA-10607-1 RF2082876 2014-08, AA-15511-S RF8122732 2013-12, AA-10507-1 RF2083221 2014-08, AA-15611-S RF8122734 2013-12, AA-15511-S RF2083300 2017-08, AA-15511-S RF9014645 2014-01, AA-10624-1 RF2083454 2014-08, AA-15611-S RF9014646 2014-01, AA-10511-1 RF2083574 2014-08, AA-15511-S RF9027936 2014-02, AA-10611-1 RF2083576 2014-08, AA-15611-S RF9027938 2014-02, AA-10624-1 RF2083577 2014-08, AA-15511-S RF9030868 2014-04, AA-10507-1 RF2083578 2014-08, AA-15611-S RF9030870 2014-04, AA-15611-S RF2083790 2017-08, AA-15511-S RF9043881 2014-05, AA-10607-1 RF2083917 2014-08, AA-15611-S RF9056723 2014-06, AA-15611-S RF2084674 2017-09, AA-15511-S RF9057834 2014-06, AA-10611-1 RF2084732 2014-09, AA-15611-S RF9069105 2014-07, AA-15511-S RF2084734 2017-09, AA-15611-S RF9070830 2014-08, AA-10511-1 RF2095165 2014-09, AA-15511-S RF9073033 2014-08, AA-10611-1 RF2096244 2014-09, AA-15611-S RF9085114 2014-08, AA-10611-1 RF2096785 2014-10, AA-15511-S RF9085142 2014-08, AA-15611-S RF9085720 2014-09, AA-15611-S RF9086531 2014-09, AA-15611-S RF9100255 2014-10, AA-15511-S RF9101704 2014-11, AA-15511-S RF9109533 2014-10, AA-15611-S RF9112368 2014-11, AA-15611-S RF9114142 2014-11, AA-15511-S RF9114143 2014-11, AA-15611-S RF9127372 2015-01, AA-15511-S RF9127374 2015-01, AA-15611-S RV0018374 2015-01, AA-15611-S RV0018375 2015-01, AA-15611-S RV0018376 2015-01, AA-15611-S RV0018927 2015-01, AA-10507-1 RV2069822 2014-06, AA-10607-1 RV2069823 2014-06, AA-10511-1 RV2069824 2014-06, AA-10611-1 RV2069826 2014-06, AA-10624-1 RV2069827 2014-06, AA-15511-3 RV2095275 2014-09, AA-15611-3 RV2095276 2014-09, AA-15611-3 RV2096130 2014-09, AA-15511-3 RV2096154 2014-09, AA-10411-1 RV2096427 2014-09, AA-10524-1 RV2096435 2014-09.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0468-2014

Related Recalls

Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1; (2) Arrow Arterial Access Tray with 0.021" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-CK; (3) Arrow Arterial Access Kit, .025 inch dia. spring-wire guide, REF ASK-04001-VAMC1; (4) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-BHS; (5) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-BID; (6) Arrow Arterial Line Kit, 20 Ga., 12 cm. catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-HMC; (7) Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-HOA; (8) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm. catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-KSD; (9) Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-LOL; (10) Arrow Radial Catheterization, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-MHS; (11) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, 018 inch dia. spring-wire guide, REF ASK-04020-MIB3; (12) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring- wire guide, REF ASK-04020-PRH; (13) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring-wire guide, REF ASK-04020-UOIL; (14) Arrow QuickFlash Radial Artery Catheterization Kit, 20 Ga., 3.81 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04220-KSP; and (15) Arrow Arterial Catheterization Kit, 20 Ga. 4.45/12 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04500-HFH4.

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Class I - Dangerous

Reports have been received regarding open seals on the packaging.

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Class I - Dangerous

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Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.

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