Class 3 Device Recall BD Oral Dispensing Syringe Oral Syringe Tip Caps

• Date Initiated by Firm: October 05, 2011
• Date Posted: February 23, 2012
• Recall Status: Terminated on February 01, 2013
• Recall Number: Z-1097-2012
• Recall Event ID: 61206
• Product Classification: Dispenser, liquid medication - Product Code KYX
• Product: 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
• Code Information: Pre-amendment device Device Listing Number R060456 Lot Number Catalog Number 0240048 305219 0267416 305207 0267418 305207 0267422 305209 0267423 305209 0267425 305217 0267426 305217 0267430 305219 0267432 305219 0294722 305210 0294726 305210 0294727 305217 0294729 305220 0294730 305220 0294731 305208 0296604 305218 0296605 305218 0296606 305218 0296607 305218 0296608 305207 0296609 305207 0296610 305217 0296611 305217 0296614 305219 0296615 305219 0323224 305207 0323225 305207 0323228 305210 0323229 305217 0323230 305218 0323231 305218 0323232 305218 0323233 305219 0323235 305220 0323329 305217 0323332 305210 0323333 305210 0323334 305220 0323335 305220 0323336 305220 1003672 305219 1003675 305219 1003679 305218 1003681 305218 1003683 305218 1003684 305207 1003686 305207 1003690 305207 1003691 305208 1003692 305208 1003693 305209 1003696 305209 1003699 305217 1027148 305207 1027150 305207 1027154 305208 1027156 305208 1027159 305209 1027161 305209 1027164 305210 1027166 305210 1027168 305217 1027174 305218 1027175 305218 1027179 305219 1027183 305219 1027184 305220 1042244 305218 1052674 305207 1052675 305207 1052676 305217 1052677 305217 1052678 305217 1052679 305208 1052680 305208 1052681 305218 1052682 305210 1052683 305220 1052684 305220 1052685 305209 1052686 305209 1052687 305219 1052688 305219 1080129 305210 1081310 305218 1081712 305208 1082759 305218 1082761 305220 1082778 305207 1082783 305217
• Recalling Firm/ Manufacturer: Becton Dickinson & Company; 1 Becton Dr; Franklin Lakes NJ 07417-1815
• For Additional Information Contact: Mr. Greg Morgan; 201-847-4344
• Manufacturer Reason for Recall: There are complaint reports for loose tip caps in various types of oral syringes
• FDA Determined Cause: Device Design
• 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.
• Quantity in Commerce: 22,827,500 units
• Distribution: (USA) Nationwide Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.