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Terminated

ESD-5, ESD Flexible Endoscopic Suturing Device, Flexible Sew Right Device: Flexible TI Knot Device: External Accessory Channel: 6mm./75 cm.; * Suture Quickload Units (2); TI Knot Quickload Units (2) * Disposable Single Use Only * Manufactured by: LSI Solutions * Sterile/EO * Rx Only * Wilson-Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.

FDA Recall Z-0698-05 · Posted 2005-04-08

Recalling FirmWilson-Cook Medical Inc
Recall StatusTerminated
Product CodeGCJ
Date Initiated2005-04-01
Date Terminated2005-07-08
Product Quantity167 units

Reason for Recall

The expiration date listed on the product label is greater than the vendor recommended expiration date.

Firm Action

Consignees were notified by certified mail on 04/01/2005.

Root Cause

Labeling False and Misleading

Distribution Pattern

Nationwide, Brazil, Canada, Hong Kong, Ireland & Pakistan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K011016LSI SOLUTIONS FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES PRODUCTLsi Solutions · 2001-04-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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