The Recall Desk
HighFDA (Devices)·Z-1746-2017·Announced 2017-04-12

BD Vacutainer Blood Collection Tubes Recalled for Stopper Pullout Risk

Becton Dickinson is recalling specific lots of BD Vacutainer Buffered Sodium Citrate blood collection tubes because stoppers may pull out during use.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a functional defect (stopper pullout) that poses a risk of harm to patients or specimens, but no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Becton Dickinson & Company is initiating a product correction for multiple lots of BD Vacutainer Buffered Sodium Citrate (9NC) Blood Collection Tubes, size 13 x 75 mm x 4.5 mL. The recall involves 13,064,500 non-expired tubes distributed worldwide and nationwide in the US.

The recall is being issued because a limited number of tubes in the affected lots may exhibit stopper pullout from the tube. This issue can occur as the user removes the needle from the stopper following specimen collection. The affected catalog numbers are 367716 and 369714, with specific lot numbers and expiration dates listed in the agency's structured data.

Healthcare facilities and users should check their inventory for the specific lot numbers and catalog numbers identified in the recall notice. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations, as the stopper pullout could compromise the integrity of the blood collection process.

The recalled product

Product
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 proces
Manufacturer
Becton Dickinson & Company
Category
Medical Device — Blood Collection Tubes
Hazard
Affected units
13,064,500

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (11)

  • Catalog Number: 367716 - Lot numbers: 5251673 with expiry 3/31/2017
  • 6064542 with expiry 9/30/17
  • 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
  • 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.

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · Becton Dickinson & Company

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