—#179169

Product

FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-B

FDA product code: CAZ — Anesthesia Conduction Kit
Device class: Class 2
Medical specialty: Anesthesiology
Affected lot / code info: Lots: 71F19A0552 71F19C0531 71F19D1772 71F19F0481 71F19G2970 71F19K1979 71F19A1876 71F19C1329 71F19D2237 71F19F0794 71F19H1056 71F19K2381 71F19A2686 71F19C2027 71F19D2580 71F19F1426 71F19H1236 71F19K2382 71F19A2926 71F19C2239 71F19E0587 71F19F2006 71F19H1300 71F19L0281 71F19B0499 71F19C2723 71F19E0689 71F19G0494 71F19H2034 71F19L0502 71F19B1222 71F19C2866 71F19E1636 71F19G1028 71F19J0768 71F19L0653 71F19B2079 71F19D0056 71F19E2838 71F19G1720 71F19J1251 71F19B2664 71F19D0839 71F19E3183 71F19G2237 71F19J2203 71F19B2849 71F19D1511 71F19F0256 71F19G2837 71F19J2204

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

An Urgent Medical Device Recall notification letter dated 1/15/20 was sent to customers. Our records indicate you have received products that are subject to this field action. We are now notifying our customers to take the following actions: 1. If you have affected stock, immediately identify product, discontinue use and quarantine any products with the product codes and lot numbers listed above. 2. To acknowledge receipt of this Urgent Medical Device Recall Notice or to return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document your receipt of this letter.

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Rd, Reading, Pennsylvania 19605-9607

Distribution

Distribution pattern: The products were distributed to the following US states: AK, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY.

Timeline

Recall initiated: 2020-01-15
Posted by FDA: 2020-01-24
Terminated: 2023-03-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #179169. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.