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

Becton Dickinson & Company: BD Microtainer PSTTubes with LH (Lithium Heparin) Part/Catalog Number:365985

Is my product affected?

BD Microtainer PSTTubes with LH (Lithium Heparin) Part/Catalog Number:365985

  • UPC 30382903659853
  • UPC 50382903659857

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

What happened

Becton Dickinson & Company is recalling BD Microtainer PST Tubes with LH (Lithium Heparin), catalog number 365985, distributed nationwide and internationally. The tubes have a damaged reservoir that may result in decreased fill volume, causing blood samples to be insufficient for testing and creating an improper blood-to-additive ratio that could produce inaccurate test results.

The recall affects multiple lot numbers, with expiration dates ranging from June 2019 through December 2019. The recall notice does not specify a remedy or course of action for affected consumers.

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: 808592N (01)30382903659853 (17)190630(10)808592N(30)50 (17)190630(10)808592N(30)200(01)50382903659857 809669N (01)30382903659853 (17)190630(10)809669N(30)50 (17)190630(10)809669N(30)200(01)50382903659857 811070N (01)30382903659853 (17)190630(10)811070N(30)50 (17)190630(10)811070N(30)200(01)50382903659857 811071N (01)30382903659853 (17)190630(10)811071N(30)50 (17)190630(10)811071N(30)200(01)50382903659857 811664N (01)30382903659853 (17)190630(10)811664N(30)50 (17)190630(10)811664N(30)200(01)50382903659857 813767N (01)30382903659853 (17)190731(10)813767N(30)50 (17)190731(10)813767N(30)200(01)50382903659857 815060N (01)30382903659853 (17)190731(10)815060N(30)50 (17)190731(10)815060N(30)200(01)50382903659857 815061N (01)30382903659853 (17)190831(10)815061N(30)50 (17)190831(10)815061N(30)200(01)50382903659857 815062N (01)30382903659853 (17)190831(10)815062N(30)50 (17)190831(10)815062N(30)200(01)50382903659857 816499N (01)30382903659853 (17)190831(10)816499N(30)50 (17)190831(10)816499N(30)200(01)50382903659857 821563N (01)30382903659853 (17)191031(10)821563N(30)50 (17)191031(10)821563N(30)200(01)50382903659857 821564N (01)30382903659853 (17)191031(10)821564N(30)50 (17)191031(10)821564N(30)200(01)50382903659857 821565N (01)30382903659853 (17)191031(10)821565N(30)50 (17)191031(10)821565N(30)200(01)50382903659857 821888N (01)30382903659853 (17)191031(10)821888N(30)50 (17)191031(10)821888N(30)200(01)50382903659857 827063N (01)30382903659853 (17)191231(10)827063N(30)50 (

Source

Official record: FDA (Device enforcement) ↗

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

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