Recalls / —
—#144842
Product
General Surgery Pack, part number 006880-3. This is a custom convenience surgical instrument disposable kit. There are multiple component in this kit and the recalled item subject to recall is Medtronic Kerlix X-Ray Detectable Laparotomy Sponges.
- FDA product code
- LRS — I.V. Start Kit
- Device class
- Class 2
- Medical specialty
- General Hospital
- Affected lot / code info
- lot 56402, 57255, 60542, and 61506
Why it was recalled
These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by Medtronic due to the potential for sterile barrier to be comprised at the packaging seal.
Root cause (FDA determination)
Packaging
Action the firm took
Aligned Medical Solutions (AMS) sent the Urgent Medical Device Recall letter, dated March 21, 2016, and the Recall Reply Form to their consignees via email. AMS informed consignees that their AMS packs (surgical kits) contained Kerlix X-Ray Detectable Laparotomy Sponge which was recalled by Medtronic. Consignees were advised to follow the over-labeling instructions and dispose the Kerlix X-Ray Detectable Laparotomy Sponge at the time the surgical kit is opened for use. Consigneeswere instructed to follow the "Instruction for placing Recall Notice Label to Packs" and label any kits remaining inventory. Consignees should return the Reply Form via fax at 407-865-7456 or call 321-527-7714 for any questions about this recall.
Recalling firm
- Firm
- Windstone Medical Packaging, Inc.
- Address
- 1602 4th Ave N, Billings, Montana 59101-1521
Distribution
- Distribution pattern
- Nationwide distribution to Louisiana and Montana.
Timeline
- Recall initiated
- 2016-03-21
- Terminated
- 2016-08-16
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #144842. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.