Recall StatusTerminated
Date Initiated2019-05-13
Date Terminated2020-08-06
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.
Firm 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).
Root Cause
Process control
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.