Vaxcel Implantable Vascular Access System - Plastic Standard Port With 9F Polyurethane Catheter, Catalog/REF No. 45-360,

FDA device recall Z-0746-2007 · posted 2007-04-14 · Terminated

Recall details

Recalling firm

Boston Scientific Corp

Reason for recall

Mispackaging: some kits of peelable sheaths/dilators may contain a 10F sheath instead of a 9F sheath--(Recalling Firm was notified by their supplier B. Braun Medical of the error)

Action taken

Boston Scientific sent Urgent Medical Device Recall Notification- Immediate Action Required letters- (dated 6/13/06) to all 11 end users via Federal Express. The letters informed the end users that some of the peelable sheaths/dilators in the Vaxcel Implantable Vascular Access kits may incorrectly contain 10F sheaths instead of 9F sheaths which had been supplied by B. Braun Medical Inc. Improper sizing of the sheath for the catheter may result in difficulty /inability to insert the catheters. The letters instructed the end users to immediately remove the affected lots from inventory, segregate the recalled product, contact Boston Scientific at 1-800-862-1284 to obtain a Return Authorization (RGA) number, pack the product in an appropriate shipping carton, affix the shipping label to the outside of the shipping carton, write the RGA number on the outside of the shipping carton, and to return the recalled product to Boston Scientific''s Distribution Center Attn: QA Returns, 500 Commander Shea Blvd., Quincy, MA 02171. Accompanying each letter was a Reply Verification Tracking Form to be completed by the end user and mailed or faxed to Boston Scientific even if the user did not have the recalled lots on hand.

Root cause

Other

Status

Terminated

Product code

LJT

Quantity affected

5

Distribution

NY, CA, MD, WA, TN.

Date initiated

2006-06-13

Date posted

2007-04-14

Date terminated

2007-04-23

Location

Glens Falls, NY

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