FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-DCS
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lots: 71F19B0226 71F19B2848 71F19D0451 71F19E0081 71F19F0245 71F19J1235 71F19B0707 71F19C0406 71F19D0826 71F19E0998 71F19F0482 71F19J2164 71F19B0935 71F19C2047 71F19D1267 71F19E1253 71F19G1938 71F19K2878 71F19B1484 71F19C2433 71F19D2474 71F19E1315 71F19G2556 71F19B1832 71F19D0055 71F19D2761 71F19E2505 71F19H2404
- 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:
- Arrow International Inc
- Reason for Recall:
- There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-DCS
Product Codes/Lot Numbers:
Lots: 71F19B0226 71F19B2848 71F19D0451 71F19E0081 71F19F0245 71F19J1235 71F19B0707 71F19C0406 71F19D0826 71F19E0998 71F19F0482 71F19J2164 71F19B0935 71F19C2047 71F19D1267 71F19E1253 71F19G1938 71F19K2878 71F19B1484 71F19C2433 71F19D2474 71F19E1315 71F19G2556 71F19B1832 71F19D0055 71F19D2761 71F19E2505 71F19H2404
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1202-2020
Related Recalls
Reports have been received regarding open seals on the packaging.
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS
ARROW INTERNATIONAL
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.
Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U
ARROW INTERNATIONAL
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.