FDA Recall Terminated

SafeSheath(R) CSG(R) Coronary Sinus guide Braided Core Hemostatic Introducer, SafeSheath(R) Worley Telescopic Braided Series, and Situs LDS2 Lead Delivery System - Catalog numbers: CSG/WORLEY/BCor-1-09; CSG/WORLEY/BCor-2-09; CSG/WROLEY/L/BCor-1-09; CSG/Worley/R-1-09; CSGWORBC10M; CSGWORBC29M; CSGWORLBC19M; LVI/66-5.5-CR; LVI/66-5.5-RE; LVI/75-5-62-07-HO; LVI/75-5-62-07-HS; LVI/75-5-62-07-MP; LVI/75-5-62-07-RE; LVI/75-5-66-5.5-RE; LVI/Tele/B-60-07-HO; LVI/Tele/B-60-07-HS; LVI/Tele/B-60-07-MP; LVI/Tele/B-60-07-RE; RL065; RL066; RL067; and RL068 This device is intended to be used for the introduction of various types of pacing or defibrillator leads and catheters.

Recall: Z-0168-2012 · Initiated October 7, 2011

Recall

Recall Number: Z-0168-2012
Event Number: 60236
Firm: Thomas Medical Products Inc
FEI Number: 3010665433
Product Code: DYB
Status: Terminated
Root Cause: Nonconforming Material/Component
Initiated: October 7, 2011
Posted: January 11, 2012
Terminated: August 29, 2012
Address: 65 Great Valley Pkwy, Malvern, PA, 19355-1302

Description

Reason

Radiopaque (RO)/soft tip of the braided core component in the CSG kits may detach from the braided core tube.

Action

The firm,GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated October 7, 2011, to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately segregate all affected product in a manner that ensures it will not be used; return any product with reference to the return authorization (RA) number or contact customer service representative to facilitate return of product; if any affected product has been forwarded to another facility, contact that facility to arrange return, and complete and return the attached product reconciliation form. If you have any questions, you may contact the Customer Service number at 1-866-446-3003 Monday through Friday from 8:30am to 5:00pm EDT.

Distribution

Nationwide distribution: CA only.

Quantity

33,134