🔍 RecallPedia

Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838

Class I - Dangerous
🏥 Medical Devices Recalled: May 25, 2022 Cook Incorporated Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI: (01)00827002028388; Lot Numbers: 9665716, 9679942, 9686540, 9686549, 9689250, 9689343, 9692548, 9692549, 9699716, 9699717, 9705738, 9709183, 9712150, 9712373, 9736455, 9742510, 9746575, 9746716, 9760404, 9760475, 9766121, 9775119, 9780326, 9782923, 9785433, 9792467, 9793490, 9799632, 9799638, 9804929, 9824019, 9826828, 9826829, 9829654, 9830524, 9836105, 9836209, 9871734, 9873996, 9889391, 9892371, 9895593, 9898132, 9898730, 9902290, 9902927, 9910485, 9916495, 9916503, 9924121, 9931357, 9931541, 9938186, 9938235, 9946241, 9952626, 9952627, 9952726, 9954044, 9954213, 9961061, 9969348, 9975178, 9976722, 9978990, 9880405, 9981888, 9999793, 9999803, 10003519, 10005927, 10009215, 10009245, 10024184, 10024217, 10024218, 10032460, 10035628, 10035750, 10044472, 10044906, 10051940, 10055076, 10108943, 10109034, 10111785, 10117980, 10121837, 10121846, 10127381, 10127456, 10130377, 10130378, 10133950, 10133956, 10133957, 10133961, 10134000, 10142279, 10145130, 10148417, 10148426, 10148473, 10148591, 10148632, 10161897, 10161961, 10164500, 10164506, 10169956, 10169957, 10190606, 10190623, 10190633, 10190677, 10195251, 10197815, 10197831, 10200912, 10200913, 10207095, 10209858, 10220200, 10220208, 10222904, 10222926, 10226192, 10229970, 10229997, 10229998, 10236738, 10243510, 10243516, 10245424, 10247563, 10251181, 10266211, 10269457, 10327125, 10327126, 10327131, 10327133, 10327134, 10327136, 10328195, 10328201, 10328210, 10331628, 13004566, 13018910, 9874017X, 9875796X, NS9880393
  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:
Cook Incorporated
Reason for Recall:
The products may contain excess coating material on the outside and/or interior of the needle component. Potential adverse events that may occur if an affected product is used include a delay in the procedure, a prolonged procedure, or particulate entering the bloodstream which may result in pulmonary embolism or ischemia.
Classification:
Class I - Dangerous

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

Status:
completed

Product Information

Full Description:

Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838

Product Codes/Lot Numbers:

UDI-DI: (01)00827002028388; Lot Numbers: 9665716, 9679942, 9686540, 9686549, 9689250, 9689343, 9692548, 9692549, 9699716, 9699717, 9705738, 9709183, 9712150, 9712373, 9736455, 9742510, 9746575, 9746716, 9760404, 9760475, 9766121, 9775119, 9780326, 9782923, 9785433, 9792467, 9793490, 9799632, 9799638, 9804929, 9824019, 9826828, 9826829, 9829654, 9830524, 9836105, 9836209, 9871734, 9873996, 9889391, 9892371, 9895593, 9898132, 9898730, 9902290, 9902927, 9910485, 9916495, 9916503, 9924121, 9931357, 9931541, 9938186, 9938235, 9946241, 9952626, 9952627, 9952726, 9954044, 9954213, 9961061, 9969348, 9975178, 9976722, 9978990, 9880405, 9981888, 9999793, 9999803, 10003519, 10005927, 10009215, 10009245, 10024184, 10024217, 10024218, 10032460, 10035628, 10035750, 10044472, 10044906, 10051940, 10055076, 10108943, 10109034, 10111785, 10117980, 10121837, 10121846, 10127381, 10127456, 10130377, 10130378, 10133950, 10133956, 10133957, 10133961, 10134000, 10142279, 10145130, 10148417, 10148426, 10148473, 10148591, 10148632, 10161897, 10161961, 10164500, 10164506, 10169956, 10169957, 10190606, 10190623, 10190633, 10190677, 10195251, 10197815, 10197831, 10200912, 10200913, 10207095, 10209858, 10220200, 10220208, 10222904, 10222926, 10226192, 10229970, 10229997, 10229998, 10236738, 10243510, 10243516, 10245424, 10247563, 10251181, 10266211, 10269457, 10327125, 10327126, 10327131, 10327133, 10327134, 10327136, 10328195, 10328201, 10328210, 10331628, 13004566, 13018910, 9874017X, 9875796X, NS9880393

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1362-2022

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