Recall Z-1493-2014— Stryker Instruments Div. of Stryker Corporation
Class II · Terminated
Class II FDA medical device recall by Stryker Instruments Div. of Stryker Corporation, initiated 2014-03-26, terminated 2014-12-11. FDA's recall record names no specific 510(k) clearance for this event. Product: Stryker PenAdapt"; Rx Only, Sterile. This device is an accessory to an electrosurgical unit (ESU). The PenAdapt is used to remove smoke, particles, and body and casual fluids from the point of surgical activity during surgical procedures that use ESU for cutting and cauterizing.. Reason: During packaging verification testing, a failure occurred due to cuts in the packaging potentially causing a breach in the sterile barrier. Additional testing identified microscopic aluminum metal shavings and foreign particles estimated in size to be between 0.01inches x 0.015 inches to 0.03 inches x 0.04 inches that were introduced during the manufacturing process and were sterilized within the.
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-03-26
- Terminated
- 2014-12-11
- Firm location
- Portage, MI, United States
Product description
Stryker PenAdapt"; Rx Only, Sterile. This device is an accessory to an electrosurgical unit (ESU). The PenAdapt is used to remove smoke, particles, and body and casual fluids from the point of surgical activity during surgical procedures that use ESU for cutting and cauterizing.
Reason for recall
During packaging verification testing, a failure occurred due to cuts in the packaging potentially causing a breach in the sterile barrier. Additional testing identified microscopic aluminum metal shavings and foreign particles estimated in size to be between 0.01inches x 0.015 inches to 0.03 inches x 0.04 inches that were introduced during the manufacturing process and were sterilized within the
Data sourced from openFDA. This site is unofficial and independent of the FDA.