BD Oral Dispensing Syringe Oral Syringe Tip Caps various sizes ( 1 mL, 3 mL, 5 mL. 10 mL BD, Franklin Lakes, NJ 07417 USA Made in USA www.bd.com Ref Numbers 305207, 305218, 305210, 305220, 305208, 305218, 305219 Product Usage: Used for the oral administration of medications
FDA Recall Z-1097-2012 · Posted 2012-02-23
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Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeKYX
Date Initiated2011-10-05
Date Terminated2013-02-01
Product Quantity22,827,500 units
Reason for Recall
There are complaint reports for loose tip caps in various types of oral syringes
Firm Action
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
Distribution Pattern
(USA) Nationwide Distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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