REF 7655405J, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741200615 - Product Usage: is designed for use when central venous catheterization is prescribed.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot No. redv2820 redv4093 redw0517 redw1152 redx1436 redx2421 redx4735 redy0645 redy3049 redz0252 redz0603 redz1577 redz2772 reen1196 reen2065 reen3257 reen4734 reep0839 reep1691 reeq0592 reeq1318 reeq2347 reer0515 reer1136 reer3474 rees0504 rees1461 rees2183 rees3127 reet0308 reet0816 reet2299 reeu0258 reeu1473 REEU2662 reeu3582 reev0163 reev1198 reew2878 reew3089 reew4300 reex2176 reez2355 reex3435
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- Bard Access Systems Inc.
- Reason for Recall:
- Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
REF 7655405J, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741200615 - Product Usage: is designed for use when central venous catheterization is prescribed.
Product Codes/Lot Numbers:
Lot No. redv2820 redv4093 redw0517 redw1152 redx1436 redx2421 redx4735 redy0645 redy3049 redz0252 redz0603 redz1577 redz2772 reen1196 reen2065 reen3257 reen4734 reep0839 reep1691 reeq0592 reeq1318 reeq2347 reer0515 reer1136 reer3474 rees0504 rees1461 rees2183 rees3127 reet0308 reet0816 reet2299 reeu0258 reeu1473 REEU2662 reeu3582 reev0163 reev1198 reew2878 reew3089 reew4300 reex2176 reez2355 reex3435
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1657-2021
Related Recalls
Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, which could lead to infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy.
BD Intraosseous Needle Kits may exhibit: 1) Increased force required to remove the stylet from intraosseous needle during placement may cause removal of the entire needle assembly and loss of intraosseous access; 2) Stylet safety mechanism may not engage as the stylet is removed; 3) Metal discs in the powered driver may stick rendering the driver unusable.
5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire Unit Label: PowerPICC REF CK000340B BARD MYPICC KIT 5F French Size Dual-Lumen 70cm Guidewire
Bard Access Systems
Catheter convenience kits contain the incorrect guidewire. Kits were labeled with 70cm guidewires, but contained a 50cm guidewire.