FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x100mm 5.0ml PLBL Gold, Catalog No. 367986
- Recall number
- Z-2056-2018
- Recalling firm
- Becton Dickinson & Company
- Product
- BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x100mm 5.0ml PLBL Gold, Catalog No. 367986
- Status
- Terminated
- Initiated
- 2018-02-13
- Posted
- 2018-06-01
- Terminated
- 2020-03-09
- Reason
- Tubes may exhibit stopper creepout/pullout, where the stopper dissociates from the tube
- Root cause
- Nonconforming Material/Component
- 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
- Quantity
- 9,568,900 total products
- Distribution
- US Nationwide, Argentina, Belize , Brazil, Canada, China, Guam, India, Japan, Mexico, Nicaragua, Pakistan, Philippines, Singapore, Suriname, Taiwan
- Lot, serial or model codes
- UDI DI (01)50382903679862 Lot/Serial# 7146901 Exp Date 5/31/2018
- 510(k) numbers
- ["K023075"]
- PMA numbers
- not on file
- Product code
- JKA
- Firm FEI
- 2243072
- Firm city
- Franklin Lakes
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28