—#172887

Product

BD Microtainer SST Part/Catalog No.365967

FDA product code: JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K002456, K991702
Affected lot / code info: Lot Number/UDI: 8094573 (01)30382903659679 (17)190630(10)8094573(30)50 (17)190630(10)8094573(30)200 (01)50382903659673 8094575 (01)30382903659679 (17)190630(10)8094575(30)50 (17)190630(10)8094575(30)200 (01)50382903659673 8094578 (01)30382903659679 (17)190630(10)8094578(30)50 (17)190630(10)8094578(30)200 (01)50382903659673 8117697 (01)30382903659679 (17)190731(10)8117697(30)50 (17)190731(10)8117697(30)200 (01)50382903659673 8165883 (01)30382903659679 (17)190831(10)8165883(30)50 (17)190831(10)8165883(30)200 (01)50382903659673 8165884 (01)30382903659679 (17)190831(10)8165884(30)50 (17)190831(10)8165884(30)200 (01)50382903659673 8170911 (01)30382903659679 (17)190831(10)8170911(30)50 (17)190831(10)8170911(30)200 (01)50382903659673 8171861 (01)30382903659679 (17)190831(10)8171861(30)50 (17)190831(10)8171861(30)200 (01)50382903659673 8220937 (01)30382903659679 (17)191031(10)8220937(30)50 (17)191031(10)8220937(30)200 (01)50382903659673 8220938 (01)30382903659679 (17)191031(10)8220938(30)50 (17)191031(10)8220938(30)200 (01)50382903659673 8282848 (01)30382903659679 (17)191231(10)8282848(30)50 (17)191231(10)8282848(30)200 (01)50382903659673 8284571 (01)30382903659679 (17)191231(10)8284571(30)50 (17)191231(10)8284571(30)200 (01)50382903659673 8284574 (01)30382903659679 (17)191231(10)8284574(30)50 (17)191231(10)8284574(30)200 (01)50382903659673

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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).

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

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

Timeline

Recall initiated: 2019-05-13
Terminated: 2020-08-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #172887. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.