FDA Device Recall Z-0034-2007: Becton Dickinson & Company

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0034-2007.

Recall Res Number

Z-0034-2007

Recalling Firm / Manufacturer

Becton Dickinson & Company

FEI Number

2243072

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2006-08-11

Date Posted

2006-10-12

Date Terminated

2007-05-08

Product Code

JAK

Event Number

36275

Product Quantity

110,300 units

Product Description 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

Reason for Recall 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.

Action Details 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.

Distribution Pattern Nationwide.

Code Information / Serial Numbers 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

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Medical Device Recall: Z-0034-2007

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer