Z-0832-03
BD First PICC 3F 65 cm Single Lumen Procedure Kit
Becton Dickinson Infusion Therapy Systems Inc. / initiated 2003-04-04 / Terminated / root cause: labeling and UDI
Becton Dickinson Infusion Therapy began a recall of BD First PICC 3F 65 cm Single Lumen Procedure Kit on . The reason FDA records is "A 4 Fr catheter was packaged in PICC convenience kits labeled as 3 Fr". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-0832-03
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Becton Dickinson Infusion Therapy Systems Inc.
- Product
- BD First PICC 3F 65 cm Single Lumen Procedure Kit.
- Product code
- LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- Reason for recall
- A 4 Fr catheter was packaged in PICC convenience kits labeled as 3 Fr.
- Root cause tag
- labeling and UDI
- FDA root cause
- Other
- Action
- All distributors and known hospitals were notified on 04/04/2003 by telephone, followed by a fax notification.
- Quantity in commerce
- 840 kits
- Distribution
- Nationwide
- Product codes and lots
- Reference No. 384134, Lot No. 2326770.
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