Recalls / —
—#163116
Product
BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x75mm 3.5ml PLBL Gold, Catalog No. 367983
- FDA product code
- JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
- Device class
- Class 2
- Medical specialty
- Clinical Chemistry
- 510(k) numbers
- K023075
- Affected lot / code info
- 1) UDI DI (01)50382903679831 PI (17)180531(10)7135828(30)1000 Lot/Serial # 7315828 Exp Date 5/31/2018 2) UDI DI (01)50382903679831 PI (17)180531(10)7146901(30)1000 Lot/Serial # 7125692 Exp Date 4/30/2018
Why it was recalled
Tubes may exhibit stopper creepout/pullout, where the stopper dissociates from the tube
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
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
Recalling firm
- Firm
- Becton Dickinson & Company
- Address
- 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815
Distribution
- Distribution pattern
- US Nationwide, Argentina, Belize , Brazil, Canada, China, Guam, India, Japan, Mexico, Nicaragua, Pakistan, Philippines, Singapore, Suriname, Taiwan
Timeline
- Recall initiated
- 2018-02-13
- Posted by FDA
- 2018-06-01
- Terminated
- 2020-03-09
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #163116. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.