—#115217

Product

BD Vacutainer PST Gel and Lithium Heparin (LH); 83 Units; Plus Blood Collection Tubes; Sterile; IVD; REF 367962; 4.5 mL, 13 X 100 mm; BD, Franklin Lakes, NJ USA; Made in USA. Used in hospitals, outpatient clinics and physicians' offices to collect blood from patients for specialized chemistry testing.

FDA product code: JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K945952
Affected lot / code info: Reference No.: 367960; Tube Size: 13 X 75. Reference Nos. 367961-367963, and 368035; Tube Size: 13 X 100; all lots

Why it was recalled

BD is conducting a recall of the BD Vacutainer Plus Plastic Plasma Separator Tube (PST) with Light Green/BD Homogard Closure due to a deformed top of the tube reservoir reported in two customer complaints.

Root cause (FDA determination)

Equipment maintenance

Action the firm took

BD sent advisory letters via UPS dated 3/5/2012 to customers. The letter identified the affected product and the reason for recall. BD has taken steps to modify the existing manufacturing and assembly processes to help reduce the potential for this condition. Questions regarding this issue should be directed to BD Global Technical Services at 1-800-631-0174 or email at www.bd.com/Vascutainer/contact.

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2012-03-05
Posted by FDA: 2013-03-06
Terminated: 2015-07-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #115217. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.