Surgical punch; sealed pouches packed in punch shelf box Intended for use by trained surgeons to create circular cuts in soft tissue or openings in soft vessel walls during surgical procedures.
Recall
- Recall Number
- Z-0813-2018
- Event Number
- 79274
- Firm
- Alto Development Corp
- FEI Number
- 2242056
- Product Code
- LRY
- Status
- Terminated
- Root Cause
- Package design/selection
- Initiated
- October 23, 2017
- Terminated
- April 30, 2019
- Address
- 5206 Asbury Rd, Wall Township, NJ, 07727-3609
Description
Surgical punch; sealed pouches packed in punch shelf box Intended for use by trained surgeons to create circular cuts in soft tissue or openings in soft vessel walls during surgical procedures.
Surgical punches are being recalled due to potential packaging damage which may have occurred during transportation resulting in loss of sterility.
A&E Medical sent an Recall Notice Action Required letter dated October 20, 2017. Surgical Punches are being recalled due to potential packaging damage which may have occurred during transportation resulting in a loss of sterility. Recent testing identified certain shipping configurations which may cause damage to the sterile barrier pouch if the Surgical Punches experience excessive movement from multiple drops during transport A&E is recalling all product currently on the market. Customer and Distributor Letters were sent with Acknowledgement Form. Product will be quarantined pending rework. For further questions, please call (800) 323-4035.
Worldwide Distribution - USA Distribution
411,486 units