Recall Z-2082-2020 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Becton Dickinson & Company
BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000435
| Date | Feb 26, 2020 |
| Status | Terminated |
| Reason | The kits contain surgical gowns which were subject to a recall by the supplier. |
| 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 BDRC6@bd.com. 3. BD |
| Quantity | 1262 total |
| Distribution | The products were distributed to the following US states: IN, MO, OH, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091324 | SHERLOCK 3CG TIP POSITIONING SYSTEM, SHERLOCK 3CG TIP POSITIONING SYSTEM STYLET C.R. Bard, Inc., Aug 7, 2009 |