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FDA (Device enforcement)Recalled 2019-05-13closedclass ii

Becton Dickinson & Company: BD Microtainer Z (No Additive Tubes) Part/Catalog No.365963

Is my product affected?

BD Microtainer Z (No Additive Tubes) Part/Catalog No.365963

  • UPC 30382903659631
  • UPC 50382903659635

Check against the official notice below — it lists the full affected range.

What happened

Becton Dickinson & Company has recalled BD Microtainer Z (No Additive Tubes), catalog number 365963, due to damaged reservoirs that may result in decreased fill volume. This defect can cause blood samples to be insufficient for testing and create an improper blood-to-additive ratio, which may produce erroneous test results. The affected product was distributed nationwide and in multiple foreign countries including Canada, Japan, Mexico, Australia, and others.

The recall involves five specific lot numbers: 8117750, 8155792, 8223778, 8223779, and 8268514. The source document does not specify what actions affected consumers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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. 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 Lot/code info: Lot Number/UDI: 8117750 (01)30382903659631 (17)191031(10)8117750(30)50 (17)191031(10)8117750(30)200 (01)50382903659635 8155792 (01)30382903659631 (17)191130(10)8155792(30)50 (17)191130(10)8155792(30)200 (01)50382903659635 8223778 (01)30382903659631 (17)200131(10)8223778(30)50 (17)200131(10)8223778(30)200 (01)50382903659635 8223779 (01)30382903659631 (17)200131(10)8223779(30)50 (17)200131(10)8223779(30)200 (01)50382903659635 8268514 (01)30382903659631 (17)200229(10)8268514(30)50 (17)200229(10)8268514(30)200 (01)50382903659635

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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