FDA Enforcement Class II Terminated

BD Microtainer SST- Amber Part/Catalog Number: 365978

Recall: Z-0058-2020 · Reported October 16, 2019

Enforcement

Recall Number
Z-0058-2020
Event ID
82851
Classification
Class II
Status
Terminated
Product Type
Devices
Firm
Becton Dickinson & Company
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
October 16, 2019
Initiation Date
May 13, 2019
Classification Date
October 7, 2019
Termination Date
August 6, 2020
Address
1 Becton Dr, N/A, Franklin Lakes, NJ, 07417-1815, United States

Description

BD Microtainer SST- Amber Part/Catalog Number: 365978

Reason

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.

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"

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

Quantity

N/A