Z-1868-2016Class II

Laparotomy Pack, Part numbers 006268-8 and 007725-8. This is a custom convenience surgical instrument...

Name: Z-1868-2016 Laparotomy Pack, Part numbers 006268-8 and 007725-8. This is a custom convenience surgical instrument...
Creator: Windstone Medical Packaging, Inc.
Published: 2016-03-21
License: https://open.fda.gov/license/

Windstone Medical Packaging, Inc. / initiated 2016-03-21 / Terminated / root cause: packaging

FDA source

Windstone Medical Packaging, Inc. began a recall of Laparotomy Pack, Part numbers 006268-8 and 007725-8. This is a custom convenience surgical instrument disposable kit. There are multiple component in this kit... on 2016-03-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1868-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-21
Posted: 2016-06-01
Terminated: 2016-08-16
Recalling firm: Windstone Medical Packaging, Inc.
Product: Laparotomy Pack, Part numbers 006268-8 and 007725-8. 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, Tray Pack, 8" x 32" W/L.
Product code: LRS I.V. Start Kit
Reason for recall: 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 tag: packaging
FDA root cause: Packaging
Action: 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.
Quantity in commerce: 386 units
Distribution: Nationwide distribution to Louisiana and Montana.
Product codes and lots: Lot: 55950, 56349, 57461, 58034, 58492, 70671, 70930, 71324, 71726, 71892, 72656, 73071, 74331, 75004, and 75545.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1868-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1868-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-06-01
Z-1869-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-06-01
Z-1870-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-06-01

Product code LRS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)