Stryker PenAdapt" recall: Foreign Material
Stryker PenAdapt"; Rx Only, Sterile. This device is an accessory to an electrosurgical unit (ESU). The PenAdapt is used to remove smoke, particles…
Why was Stryker PenAdapt" recalled?
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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part Number 0702-045-027
- Product
- Stryker PenAdapt"; Rx Only, Sterile. This device is an accessory to an electrosurgical unit (ESU). The PenAdapt is used to remove smoke, particles…
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Quantity
- 35,310 unexpired units
- Distribution
- Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV,and WY, and the countries of Austria, Canada, Sweden, England, UAE, Netherlands, Spain, and Hong Kong.
- Recall date
- April 30, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)