Vitrectomy Pack, part number AMS4952 Product packaged in a convenient manner for use in a general clinical procedure

FDA device recall Z-1800-2017 · posted 2017-04-11 · Terminated

Recall details

Recalling firm

Windstone Medical Packaging, Inc.

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.

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

FSY

Quantity affected

100 kits

Distribution

Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.

Date initiated

2017-03-16

Date posted

2017-04-11

Date terminated

2017-06-06

Location

Billings, MT