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U.S. Department of Health and Human Services

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

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 Class 3 Device Recall BD Oral Dispensing Syringe Oral Syringe Tip Caps see related information
Date Posted February 23, 2012
Recall Status1 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 2
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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