—#179170

Product

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

FDA product code: CAZ — Anesthesia Conduction Kit
Device class: Class 2
Medical specialty: Anesthesiology
Affected lot / code info: 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

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 #179170. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.