ClearanceBrief
Recall Z-2077-2020 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

Becton Dickinson & Company

BARD MYPICC KIT 4F Single-Lumen, Catalog Number CK000276

DateFeb 26, 2020
StatusTerminated
ReasonThe kits contain surgical gowns which were subject to a recall by the supplier.
Root causeUnder Investigation by firm
ActionURGENT: 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
Quantity1262 total
DistributionThe products were distributed to the following US states: IN, MO, OH, and TX.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K091324SHERLOCK 3CG TIP POSITIONING SYSTEM, SHERLOCK 3CG TIP POSITIONING SYSTEM STYLET
C.R. Bard, Inc., Aug 7, 2009