—#173062

Product

BD Microtainer SST- Amber Part/Catalog Number: 365978

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: 8193502 (01)30382903659785 (17)190930(10)8193502(30)50 (17)190930(10)8193502(30)200(01)50382903659789 8193507 (01)30382903659785 (17)190930(10)8193507(30)50 (17)190930(10)8193507(30)200(01)50382903659789 8193511 (01)30382903659785 (17)190930(10)8193511(30)50 (17)190930(10)8193511(30)200(01)50382903659789 8204927 (01)30382903659785 (17)190930(10)8204927(30)50 (17)190930(10)8204927(30)200(01)50382903659789 8205758 (01)30382903659785 (17)190930(10)8205758(30)50 (17)190930(10)8205758(30)200(01)50382903659789 8207774 (01)30382903659785 (17)190930(10)8207774(30)50 (17)190930(10)8207774(30)200(01)50382903659789 8208542 (01)30382903659785 (17)190930(10)8208542(30)50 (17)190930(10)8208542(30)200(01)50382903659789 8208544 (01)30382903659785 (17)190930(10)8208544(30)50 (17)190930(10)8208544(30)200(01)50382903659789 8232513 "(01)30382903659785 (17)191031(10)8232513(30)50 (17)191031(10)8232513(30)200(01)50382903659789 8233967 (01)30382903659785 (17)191031(10)8233967(30)50 (17)191031(10)8236756(30)200(01)50382903659789 8236755 (01)30382903659785 (17)191031(10)8236755(30)50 (17)191031(10)8236755(30)200(01)50382903659789 8236756 (01)30382903659785 (17)191031(10)8236756(30)50 (17)191031(10)8233967(30)200(01)50382903659789 8239857 (01)30382903659785 (17)191031(10)8239857(30)50 (17)191031(10)8239857(30)200(01)50382903659789 8260948 (01)30382903659785 (17)191130(10)8260948(30)50 (17)191130(10)8260948(30)200(01)50382903659789 8262866 (01)30382903659785 (17)191130(10)8262866(30)50 (17)191130(10)8262866(30)200(01)50382903659789 8282812 (01)30382903659792 (17)191231(10)8282812(30)50 (17)191231(10)8282812(30)200(01)50382903659796"

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 #173062. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.