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

Becton Dickinson & Company: BD Microtainer Tubes with LH (Lithium Heparin) Part/Catalog No.365965

Is my product affected?

BD Microtainer Tubes with LH (Lithium Heparin) Part/Catalog No.365965

  • UPC 30382903659655
  • UPC 50382903659659

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

What happened

Becton Dickinson & Company is recalling BD Microtainer Tubes with LH (Lithium Heparin), catalog number 365965, distributed nationwide and internationally. The tubes may have a damaged reservoir that reduces the amount of blood collected, resulting in insufficient sample volume for testing and an improper ratio of blood to additive. This defect could cause blood test results to be inaccurate.

The affected product includes specific lot numbers: 811767N, 815066N, 821471N, and 821990N, with expiration dates ranging from September 2019 through January 2020. The recall record does not specify what remedy consumers or healthcare providers should pursue.

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: 811767N (01)30382903659655 (17)190930(10)811767N(30)50 (17)190930(10)811767N(30)200 (01)50382903659659 2019-09-30 815066N (01)30382903659655 (17)191130(10)815066N(30)50 (17)191130(10)815066N(30)200 (01)50382903659659 821471N (01)30382903659655 (17)200131(10)821471N(30)50 (17)200131(10)821471N(30)200 (01)50382903659659 821990N (01)30382903659655 (17)200131(10)821990N(30)50 (17)200131(10)821990N(30)200 (01)50382903659659

Source

Official record: FDA (Device enforcement) ↗

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

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