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Terminated

ReliOn Insulin Syringe 0.5cc 30 Gauge 5/16 inch (8mm) Needle (U-100 Insulin). NDC 81306-0515-23.

FDA Recall Z-0569-05 · Posted 2005-03-03

Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeFMF
Date Initiated2004-10-22
Date Terminated2006-04-14
Product Quantity1543000 syringes

Reason for Recall

Syringes labeled as 5/16 inch product (30 ga) actually contained the 1/2 inch product (28 ga).

Firm Action

BD has sent letters to the distributor McKesson Inc and the retailer Wal-Mart Inc.

Root Cause

Other

Distribution Pattern

The syringes were sent to McKesson Corp, 120 Senlac Drive, Carrollton, TX 75006 who then sold them to Wal-Mart Corp, 702 SW 8th Street, Bentonville, AR 72716. There are no other customers.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K955235B-D ULTRA FINE II, MICRO FINE + SHORT NEEDLE INSULIN SYRINGEBd Becton Dickinson Vacutainer Systems Preanalytic · 1996-02-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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