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.
FDA Recall Z-0813-2018 · Posted None
Recalling FirmAlto Development Corp
Recall StatusTerminated
Product CodeLRY
Date Initiated2017-10-23
Date Terminated2019-04-30
Product Quantity411,486 units
Reason for Recall
Surgical punches are being recalled due to potential packaging damage which may have occurred during transportation resulting in loss of sterility.
Firm Action
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.
Root Cause
Package design/selection
Distribution Pattern
Worldwide Distribution - USA Distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.