—#110423

Product

Case Carton: BD Oral Dispensing Syringe 1 mL Clear with Tip Cap BD, Franklin Lakes, NJ 07417 USA Made in USA www.bd.com BD, Laagstraat 57, B-9140 Temse, Belgium On 100 unit plastic bag: BD oral syringes are intended to dispense oral medications.

FDA product code: FMF — Syringe, Piston
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K980987
Affected lot / code info: Device Listing Number - R060456 REF Lot # 305217 2076404 305217 2055156 305217 2020057 305217 2020056 305219 1346419

Why it was recalled

BD received a complaint report for mixed syringe tips (oral and non-oral syringe tips) within the same lot.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

Becton Dickinson sent a Urgent Product Recall letter/Customer Packing list dated October 2, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to review inventory and determine if they have any of the affected product. If so, it should be removed from inventory. The enclosed customer list should be completed as well. Any questions please call 1-201-847-4267.

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: (USA) nationwide

Timeline

Recall initiated: 2012-10-02
Posted by FDA: 2012-12-19
Terminated: 2016-05-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #110423. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.