Z-2081-2020Class II
BARD MYPICC KIT 4F Dual-Lumen, Catalog Number CK000418B
Becton Dickinson & Co / initiated 2020-02-26 / Terminated / root cause: supplier
Becton Dickinson & Company began a recall of BARD MYPICC KIT 4F Dual-Lumen, Catalog Number CK000418B on . FDA classified it as Class II and gives the reason as "The kits contain surgical gowns which were subject to a recall by the supplier". As of , the recall status on record is Terminated, and MDM tags the root cause as supplier.
Recall record
- Recall number
- Z-2081-2020
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Becton Dickinson & Co
- Product
- BARD MYPICC KIT 4F Dual-Lumen, Catalog Number CK000418B
- Product code
- LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- Reason for recall
- The kits contain surgical gowns which were subject to a recall by the supplier.
- Root cause tag
- supplier
- FDA root cause
- Under Investigation by firm
- Action
- URGENT: MEDICAL DEVICE RECALL notification letters dated 2/26/20 were sent to customers. YOU NEED TO TAKE THE FOLLOWING ACTIONS: 1. Immediately examine your inventory for the product code and lot numbers listed in Attachment A. Quarantine any unused product subject to this recall. Immediately discontinue the use and distribution of the affected kits. Please share this recall notification with all users of the product to ensure they are also aware of the recall. 2. Please complete the attached Business Response Form and fax to: 1-312-949-0230 or email the completed form to [email protected]. 3. BD will contact you to provide instructions for returning impacted product kits and for obtaining credit upon receipt of the response form. 4. If you have further distributed this product, please identify your customers and inform them of this notification at once. You may include a copy of this letter in your notification to your customers. NOTE: If you do not have any of the affected lots in your inventory, please complete the Recall Response Form indicating you have zero (0) quantity and return the completed form so that BD receives an acknowledgement of your receipt of this recall notification. Actions Taken by BD: BD will provide credit for the returned recalled product and will work with you to place orders for alternate devices. Contact Information: If you have any questions or require assistance with the return of the recalled product, please contact BD at 1-800-290-1689 between 8 AM and 5 PM MST Monday through Friday.
- Quantity in commerce
- 1262 total
- Distribution
- The products were distributed to the following US states: IN, MO, OH, and TX.
- Product codes and lots
- Lot Numbers: 18OB4421 18PB2141 19CBK655 19FBJ721 19GBG835 19KBJ097 19TBD597
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2075-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2076-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2077-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2078-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2079-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2080-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2081-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2082-2020 | Class II | Terminated | Voluntary: Firm initiated |
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