Recall Z-2055-2018 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Becton Dickinson & Company
BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x75mm 3.5ml PLBL Gold, Catalog No. 367983
| Date | Jun 1, 2018 (initiated Feb 13, 2018) |
| Status | Terminated |
| Reason | Tubes may exhibit stopper creepout/pullout, where the stopper dissociates from the tube |
| Root cause | Nonconforming Material/Component |
| Action | On March 15, 2018 BD Life Sciences sent Urgent Medical Device Recall Notifications to affected customers. Customers were instructed to : 1. Immediately review your inventory for the subject lots and quarantine the product subject to the recall. 2. Share this recall notification with all users of the product to ensure they are also aware of this recall. 3. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification and process your product repla |
| Quantity | 9,568,900 total products |
| Distribution | US Nationwide, Argentina, Belize , Brazil, Canada, China, Guam, India, Japan, Mexico, Nicaragua, Pakistan, Philippines, Singapore, Suriname, Taiwan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023075 | BD VACUTAINER PLUS SST SERUM SEPARATOR TUBE Bd Vacutainer Systems Preanalyical Solutions, Nov 25, 2002 |