Recall Z-0752-2017
Integra York PA, Inc · initiated October 28, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Metzenbaum Scissors 7, Curved, Sterile The Metzenbaum Scissors 7, Curved Curved are single-use sterile surgical instruments intended for cutting and grasping tissue in general surgical procedures.
Codes / lots: Catalog # ST5-182; lot# 355
Reason for recall
The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate causing the packages to open and compromise sterility of the instrument.
FDA-determined cause: Process control
Action taken
The firm, Integra, mailed an "URGENT MEDICAL DEVICE RECALL NOTICE" dated October 26, 2016 to customers affected by the recall to notify them of the issue. The notice described the product, problem and actions to be taken. The customers were instructed to immediately review their inventory to determine if they had any of the recalled product on hand and to discontinue distributing the product; review your customer traceability records for shipment of the product and forward a copy of this Recall Notice to any of your customers that purchased the affected lots; complete and return the Acknowledgement Form that accompanied the notice (even if you do not have any product(s)) by email to: FCA3@integralife.com or fax to: 1-609-750-4220. Should you have any questions regarding these instructions, please contact Customer Service at 1-866-854-8300.
Details
- Recall number
- Z-0752-2017
- Initiated
- October 28, 2016
- Posted by FDA
- December 13, 2016
- Terminated
- April 17, 2017
- Product code
- LRW – Scissors, General, Surgical
- Quantity
- 50 units
- Distribution
- US Distribution in NC and TX.
- Recalling firm
- Integra York PA, Inc, York, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0751-2017 Class II | Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile. The Rochester-Pean Hemostatic…The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate causing the… | 10/28/2016Terminated |