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FDA (Device enforcement)Recalled 2017-03-16closedclass ii

Becton Dickinson & Company: BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes, 4.5 mL, 13 x 75 mm, Mfd: Becton Dickinson and Company Product Usage: The BD Vacutainer Safety Coagulati

Is my product affected?

BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes, 4.5 mL, 13 x 75 mm, Mfd: Becton Dickinson and Company Product Usage: The BD Vacutainer Safety Coagulation tube is an evacuated blood collection Tube that provides means of collecting, transporting and processing blood in a closed t

  • UPC 30382903677161
  • UPC 30382903697145

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

What happened

Becton Dickinson & Company is correcting multiple lots of BD Vacutainer Buffered Sodium Citrate (9NC) Blood Collection Tubes measuring 13x75 mm and containing 4.5 mL. A limited number of tubes in these lots may have stoppers that pull out of the tube when users remove the needle from the stopper after collecting a blood specimen. The affected tubes were distributed worldwide and in the U.S., and approximately 13,064,500 non-expired tubes are involved across multiple lot numbers with expiration dates ranging from March 2017 through February 2018.

The affected lot numbers are identified by two catalog numbers: 367716 (with four affected lots) and 369714 (with nine affected lots). Some lots including 6064542, 6187520, and 6253669 were distributed only outside the U.S. market. The recall notice does not specify a remedy or recommended consumer action.

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

Hazard

BD is initiating this product correction of multiple lots of BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (13x75 mm x 4.5 mL). A limited number of tubes in these lots may exhibit stopper pullout from the tube as the user removes the needle from the stopper following specimen collection.

Details from the source

Reason for recall: BD is initiating this product correction of multiple lots of BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (13x75 mm x 4.5 mL). A limited number of tubes in these lots may exhibit stopper pullout from the tube as the user removes the needle from the stopper following specimen collection. Distribution: Worldwide - US Nationwide Distribution Quantity: 13,064,500 tubes (non-expired) Lot/code info: Catalog Number: 367716 - Lot numbers: 5251673 with expiry 3/31/2017; 6064542 with expiry 9/30/17; 6187520 with expiry 1/31/2018 and 6253669 with expiy 3/31/18 Catalog Number: 369714 - Lot numbers: 5272777 with expiry 4/30/17; 5336909 with expiry 6/30/17; 5357632 with expiry 7/31/17; 6040953 and 6064634 both with expiry 9/30/17; 6090572 with expiry 10/31/17; 6124932 with expiry 11/30/17; 6173983 with expiry 12/31/17; 6187600 with expiry 1/31/18 and 6216656 with expiry 2/28/18 Lot numbers 6064542, 6187520 and 6253669 - limited to distribution outside the U.S. market. UDI for lot 6253669 is DI (01)30382903677161, PI (17)180331(10)6253669(30)0100 and lot 6216656 is DI (01)30382903697145, PI (17)180228(10)6216656(30)0100; for all other lots UDI is not applicable based on manufacture date.

Source

Official record: FDA (Device enforcement) ↗

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

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