—#48313

Product

BD Vacutainer Push Button Blood Collection Set with Pre-attached Holder. Non-pyrogenic 100. Rx only, sterile REF 368656 23G x 3/4'' x 12'' 0.6 x 19mm x 305mm ----- REF 367352 21G x 3/4'' x 12'' 0.8 x 19mm x 305mm

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K011984
Affected lot / code info: Catalog number 367352 Lot # 6100596 Catalog number 367352 Lot # 6100597 Catalog number 367352 Lot # 6152413 Catalog number 368656 Lot # 6090251 Catalog number 368656 Lot # 6094813 Catalog number 368656 Lot # 6094840 Catalog number 368656 Lot # 6111757 Catalog number 368656 Lot # 6121663 Catalog number 368656 Lot # 6146186

Why it was recalled

A complaint was received regarding a BD blood collection set where the blister was noticeably warped. The seal width was below minimum specification. Some blisters could adhere together and crack upon separation. Some units may have pre-activated or have defects affecting package integrity.

Root cause (FDA determination)

Other

Action the firm took

Recall notification were mailed out first class mail, return receipt requested, approximately 8/24/2006 to distributors, who were then asked to contact their customers.

Recalling firm

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

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2006-08-11
Posted by FDA: 2006-10-12
Terminated: 2007-05-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #48313. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.