Dr. Wischmeier Pack, part numbers: AMS3509 and AMS3509(A Product packaged in a convenient manner for use in a general clinical procedure
- Recall Initiated
- March 16, 2017
- Posted
- April 11, 2017
- Terminated
- June 6, 2017
- Recall Number
- Z-1788-2017
- Quantity
- 1,170 kits
- Firm Location
- Billings, MT
Reason for Recall
AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.
Distribution
Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.
Lot / Code Info
Lot numbers: 75870 78661 79154 81580 81800 83500 83594 83680 84118 84262 86073 86485 86887 87119 89180 95109 95422 95809 96760 97589 98512 99060 100410 101234
Root Cause
Nonconforming Material/Component
Action Taken
AMS sent an Urgent Medical Device Recall letter dated March 16, 2017, and provided yellow stickers "Recall Notice" to customers. They are advised to over-label the affected AMS kits at their facilities. Customers were instructed to place sticker in such a way that it would be immediately noticed but should not cover up or conceal any pertinent information such as Pack Number, Pack Name, Lot Number or Expiration Date on a kit. Customers should check inventory and complete the Recall Reply Form. Fax the completed form to Aligned Medical Solutions at 407-804-8460 or email the completed form to vdavis@alignedmedicalsolutions.com. Customers can call Aligned Medical Solutions at 321-527-7714.