| Date Initiated by Firm |
September 09, 2005 |
| Date Posted |
September 14, 2005 |
| Recall Status1 |
Terminated 3 on May 08, 2006 |
| Recall Number |
Z-1398-05 |
| Recall Event ID |
33335 |
| Product Classification |
General Surgery Tray - Product Code LRO
|
| Product |
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***
|
| Code Information |
Lots: 385569 386370 388085 380910 385604 386873 386153 388558 387906 386224 385726 386714 386721 386142 387590 386731 386732 386337 385262 386756 383386 383385 385819 386706 385980 386074 386472 385660 386649 386409 384525 386543 386410 385493 386849 385945 387453 386357 388777 385542 |
Recalling Firm/
Manufacturer |
Avid Medical Inc
9000 Westmont Drive
Stonehouse Commerce Park
Toano VA 23168
|
| For Additional Information Contact |
JoAnn Shepard
888-564-7153
|
Manufacturer Reason
for Recall |
Defect in packaging of medical devices may compromise sterility of these products used in medical and surgical procedures.
|
FDA Determined
Cause 2 |
Other |
| 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. |
| Quantity in Commerce |
4281 kits |
| Distribution |
The product was sold to distributors and end user medical facilities nationwide. |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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