Recalls / —
—#145144
Product
Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection
- FDA product code
- FMF — Syringe, Piston
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K110771
- Affected lot / code info
- Catalog (REF #) 309642, Lot #'s 4163814, 4252723, 4252726, 4252729, 4293878, 4340516, 5017729 and 5017735
Why it was recalled
BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Schein 10 mL Single Use Syringe Luer-Lock are being recalled due to possible adulteration and non-conforming manufacturing practices.
Root cause (FDA determination)
Error in labeling
Action the firm took
Becton Dickinson sent via email and UPS Ground an "Urgent Voluntary Product Recall" Letter dated March 25, 2016 along with a Recall Response Form and packaging instructions to their sole customer. Customers were instructed to immediately review their inventory , quarantine any affected product, and immediately discontinue shipment of the affected product. Customers should complete the Recall Response Card from and fax it to BD at 1-201-847-6990. Return all affected product with the completed Recall Response Card. If product was further distributed please identify your customers and notify them immediately of the product recall. Customers were also instructed to complete the Recall Response Form even if they do not have any affected lots in their inventory. Customers with questions were instructed to call 1-201-847-4267. For questions regarding this recall call 201-847-5612.
Recalling firm
- Firm
- Becton Dickinson & Company
- Address
- 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815
Distribution
- Distribution pattern
- Nationwide Distribution to NY only
Timeline
- Recall initiated
- 2016-03-25
- Terminated
- 2017-04-03
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #145144. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.