Recall StatusTerminated
Date Initiated2018-02-13
Date Terminated2020-03-09
Product Quantity9,568,900 total products
Reason for Recall
Tubes may exhibit stopper creepout/pullout, where the stopper dissociates from the tube
Firm Action
On March 15, 2018 BD Life Sciences sent Urgent Medical Device Recall Notifications to affected customers. Customers were instructed to : 1. Immediately review your inventory for the subject lots and quarantine the product subject to the recall.
2. Share this recall notification with all users of the product to ensure they are also aware of this recall.
3. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification and process your product replacement.
Return all affected products using the enclosed packaging instructions and include the completed Recall Response Form with the product.
4. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program. Web: Medwatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-800-332-1088); Mail: MedWatch, HF-2, FDA 5600 Fisher's Lane, Rockville, MD 20853-9787. Customer who require further assistance should contact BD Preanalytical Systems at (877)870-4486, Mon-Fri 8:00am-5:00pm
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide, Argentina, Belize , Brazil, Canada, China, Guam, India, Japan, Mexico, Nicaragua, Pakistan, Philippines, Singapore, Suriname, Taiwan
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.