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

Becton Dickinson & Company: BD Microtainer SST Part/Catalog No.365967

Is my product affected?

BD Microtainer SST Part/Catalog No.365967

  • UPC 30382903659679
  • UPC 50382903659673

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

What happened

Becton Dickinson & Company is recalling BD Microtainer SST blood collection tubes, catalog number 365967, distributed nationwide and internationally. The tubes have a defective reservoir that may not fill properly, resulting in insufficient blood samples and an incorrect ratio of blood to additive, which could cause laboratory test results to be inaccurate.

The recall affects multiple lot numbers produced between June and December 2019, including lots 8094573, 8094575, 8094578, 8117697, 8165883, 8165884, 8170911, 8171861, 8220937, 8220938, 8282848, 8284571, and 8284574. The source document does not specify what affected consumers should do regarding 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: 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

Source

Official record: FDA (Device enforcement) ↗

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

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