BD Oral Dispensing Syringe Oral Syringe Tip Caps various sizes ( 1 mL, 3 mL, 5 mL. 10 mL BD, Franklin Lakes, NJ 07417 US

FDA device recall Z-1097-2012 · posted 2012-02-23 · Terminated

Recall details

Recalling firm

Becton Dickinson & Company

Reason for recall

There are complaint reports for loose tip caps in various types of oral syringes

Action taken

Becton Dickinson (BD) sent an Urgent: Product Recall letters dated October 5, 2011 to all affected consignees. The letter identifies the affected product, problem and actions to be taken. Customers are instructed to follow the instructions on how to handle the affected product: 1) Check their inventory to determine if they have any Oral Syringe Tip Caps from the impacted lot numbers. 2) If they have any of the impacted product return the Oral Syringe Tip Caps to BD for replacements as directed on the attached recall packing list. 3) If they use the Oral Syringe Tip Caps and require replacement, follow the instructions on the attached form. 4) If they have no inventory of the affected lots, indicate this on the website.

Root cause

Device Design

Status

Terminated

Product code

KYX

Quantity affected

22,827,500 units

Distribution

(USA) Nationwide Distribution

Date initiated

2011-10-05

Date posted

2012-02-23

Date terminated

2013-02-01

Location

Franklin Lakes, NJ