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Terminated

Custom Procedure Trays, containing various configurations of medical and surgical devices, packed in plastic pouches, labeled in part ***Avid Medical, The custom procedure tray company Toano, Virginia 23168***Sterile~Disposable~Single Use Only***, and further identified by the following catalog numbers: BOOZ001-01 CATARACT PACK*** VMLR0009-05 FEM POP*** AZSS001-01 SINGLE SHOT EPIDURAL TRAY*** META026-01 SHOULDER*** MPOC002-02 ARTHROSCOPY PACK*** MMMC002 UNIVERSAL ARTHROSCOPY PACK*** ORHS023-03 OBSTETRICAL PACK W/POUCH*** MSCB002-02 BASIC PACK*** ADVH002-08 OPEN HEART KLICH PACK*** ADVM005-02 PACEMAKER-IL MASONIC*** CILS004-03 EXTREMITY PACK*** NOIN004 ARTHROGRAM PACK*** RMRI036-11 TOTAL JOINT PACK*** NRSC0003-06 ARTHROSCOPY PACK*** AV10584-03 COMMUNITY RETINAL DETACHMENT*** STJN030-02 HEART DRAPE TRAY*** STJN045 HEART OFF PUMP*** PHLS008-04 SPECIAL PROCEDURES PACK*** UHSN035-02 TOTAL KNEE*** SLIZ004a-02 CATH TRAY*** NYOD008 Abdominal Preservation Kit*** NYOD011 PEDIATRIC ABDOMINAL*** FAMC017-05 MAJOR BASIN SET*** AGAK005-04 BASIN SET-SURGERY CENTER*** AV010773-02 C-SECTION PACK*** OSUM018-04 OPHTHALMOLOGY CUSTOM TRAY*** KENT005-01 CAROTID*** HVCCA-10 HEART PACK*** SUMM004-04 Harris Basic*** MCVA0020-07 BUNDLE, EYE*** MCVA0025-04 BUNDLE, LOWER EXTREMITY*** MCVA0033-06 PDS, MAJOR EAR*** MCVA0039-06 PDS, TOTAL KNEE*** MCVA0044-02 PACEMAKER PACK*** NAPO0014-04 LAP CHOLE CUSTOM TRAY*** NAPO0025-05 HAND & PODIATRY TRAY*** NAPO0061-02 ABDOMINOPLASTY CUSTOM TRAY*** LIFE0027-06 C.V. TRANSPORT BOX*** WIAS002-01 UNIVERSAL BLOCK TRAY*** UMCW013-07 TOTAL KNEE PDS***

FDA Recall Z-1398-05 · Posted 2005-09-14

Recalling FirmAvid Medical Inc
Recall StatusTerminated
Product CodeLRO
Date Initiated2005-09-09
Date Terminated2006-05-08
Product Quantity4281 kits

Reason for Recall

Defect in packaging of medical devices may compromise sterility of these products used in medical and surgical procedures.

Firm Action

The recalling firm notified distributors and end users by letter 09/07/05. The notification advised of product packaging in which seal integrity may have been compomised. The recall letter lists specific lots and item numbers of the custom trays to be returned for replacement or reimbursement. A response form is included in the notification.

Root Cause

Other

Distribution Pattern

The product was sold to distributors and end user medical facilities nationwide.

Official Source

View FDA Recall →

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

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