—#37398

Product

Arrow Continuous Nerve Block Needle, Latex-Free* Rx only*Sterile*Arrow International Inc., 2400 Bernville, Road, Reading, PA 19605 USA

FDA product code: CAZ — Anesthesia Conduction Kit
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K021567
Affected lot / code info: Product #AB-17040-N, AB-17080-N, AB-17110-N, AB-17140-N, AB-18040-N, AB-18080-N, AB-18110-N, AB-18140-N, AB-19604-K, AB-19604-S, AB-19608-K, AB-19608-S, AB-20604-K, AB-20604-S, AB-20608-K, AB-20608-S

Why it was recalled

Possible difficulty in passing the catheter through the needle due to a reduced ID of the needle caused by over crimping of the needle during the manufacturing process.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notifed by letter on/about 02/17/2005

Recalling firm

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

Distribution

Distribution pattern: Nationwide, Africa , France, Holland, Rotterdam

Timeline

Recall initiated: 2005-02-17
Posted by FDA: 2005-06-01
Terminated: 2006-05-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #37398. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.