Recalls / —

—#40583

Product

Banana Peel™ Sheaths BP/12/30 Catalog Number : 20-614

FDA product code

KOB — Catheter, Suprapubic (And Accessories)

Device class

Class 2

Medical specialty

Gastroenterology, Urology

510(k) numbers

K961219

Affected lot / code info

Lot Numbers:  6458185 6458744 6525656 6620737 6646575 6661845 6701154 6774282 6803138 6815881 6844359 6887566 6938752 6956272 7021163 7038591 7069888 7091051 7105145 7172814 7358085 7401873 7532022 7571550 7739650

Why it was recalled

The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.

Root cause (FDA determination)

Other

Action the firm took

Boston Scientific intiated the recall on 7/22/05 to direct accounts and to distributors on 7/ 27 /05. Distributors are requested to conduct sub recalls to the medical facility level. A revised letter dated 8/2/05 was sent to 18 US accounts for one lot (#1020895) omitted in the letter of 7/22/05.

Recalling firm

Firm

Boston Scientific Corporation

Address

1 Boston Scientific Pl, Natick, Massachusetts 01760-1536

Distribution

Distribution pattern

Nationwide VA Hopsitals Foreign: Canada, Africa, Japan, Israel, Japan, Nertherlands, Venezula

Timeline

Recall initiated

2005-07-22

Posted by FDA

2005-09-02

Terminated

2007-06-20

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #40583. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.