| Date Initiated by Firm | May 13, 2019 |
|---|
| Create Date | October 07, 2019 |
|---|
| Recall Status1 |
Terminated 3 on August 06, 2020 |
| Recall Number | Z-0059-2020 |
|---|
| Recall Event ID |
82851 |
| 510(K)Number | K002456 K991702 |
|---|
| Product Classification |
Tubes, vials, systems, serum separators, blood collection - Product Code JKA
|
| Product | BD Microtainer PSTTubes with LH (Lithium Heparin)
Part/Catalog Number:365985 |
|---|
| Code Information |
Lot Number/UDI: 808592N (01)30382903659853 (17)190630(10)808592N(30)50 (17)190630(10)808592N(30)200(01)50382903659857 809669N (01)30382903659853 (17)190630(10)809669N(30)50 (17)190630(10)809669N(30)200(01)50382903659857 811070N (01)30382903659853 (17)190630(10)811070N(30)50 (17)190630(10)811070N(30)200(01)50382903659857 811071N (01)30382903659853 (17)190630(10)811071N(30)50 (17)190630(10)811071N(30)200(01)50382903659857 811664N (01)30382903659853 (17)190630(10)811664N(30)50 (17)190630(10)811664N(30)200(01)50382903659857 813767N (01)30382903659853 (17)190731(10)813767N(30)50 (17)190731(10)813767N(30)200(01)50382903659857 815060N (01)30382903659853 (17)190731(10)815060N(30)50 (17)190731(10)815060N(30)200(01)50382903659857 815061N (01)30382903659853 (17)190831(10)815061N(30)50 (17)190831(10)815061N(30)200(01)50382903659857 815062N (01)30382903659853 (17)190831(10)815062N(30)50 (17)190831(10)815062N(30)200(01)50382903659857 816499N (01)30382903659853 (17)190831(10)816499N(30)50 (17)190831(10)816499N(30)200(01)50382903659857 821563N (01)30382903659853 (17)191031(10)821563N(30)50 (17)191031(10)821563N(30)200(01)50382903659857 821564N (01)30382903659853 (17)191031(10)821564N(30)50 (17)191031(10)821564N(30)200(01)50382903659857 821565N (01)30382903659853 (17)191031(10)821565N(30)50 (17)191031(10)821565N(30)200(01)50382903659857 821888N (01)30382903659853 (17)191031(10)821888N(30)50 (17)191031(10)821888N(30)200(01)50382903659857 827063N (01)30382903659853 (17)191231(10)827063N(30)50 (17)191231(10)827063N(30)200(01)50382903659857 827064N (01)30382903659853 (17)191231(10)827064N(30)50 (17)191231(10)827064N(30)200(01)50382903659857 827589N (01)30382903659853 (17)191231(10)827589N(30)50 (17)191231(10)827589N(30)200(01)50382903659857 827693N (01)30382903659853 (17)191231(10)827693N(30)50 (17)191231(10)827693N(30)200(01)50382903659857 827699N (01)30382903659853 (17)191231(10)827699N(30)50 (17)191231(10)827699N(30)200(01)50382903659857" |
Recalling Firm/
Manufacturer |
Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
|
| For Additional Information Contact | SAME
201-847-6800 |
|---|
Manufacturer Reason
for Recall | Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results. |
|---|
FDA Determined
Cause 2 | Process control |
|---|
| Action | Becton Dickinson (BD) notified consignees affected by letter via UPS and email dated May 13,2019. Letter describes reason for recall, health risk and action to take: 1. Immediately review your inventory for the specific catalog and lot numbers listed below, 2. Destroy all product subject to the recall following your institution's process for destruction, 3. Share this Urgent Medical Device Recall notification with all users of the product to ensure that they are also aware of this recall, and 4. Complete the attached Customer Response/Certificate of Destruction Forms 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 replacement. Distributors provide their customer list to BD. BD PAS will notify these customers via mail.
BD Contact US Contact Information Customer/Technical Support
888-237-2762 OPT 3, OPT 2; Monday Friday 8:00am - 5:00pm (CT). |
|---|
| Distribution | Nationwide
Foreign:
AR
AU
BE
BN
BR
CA
CL
CN
CO
CR
CW
EC
GT
GY
HK
HN
ID
IN
JP
KR
MX
MY
NI
NZ
PA
PE
PG
PH
PK
SG
SR
SV
TH
TW
UY
VN |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = JKA
|
|---|
