Z-0194-2017Class II

General Pack I, Kit number CMP1811(B convenience custom kits used for general surgery in hospital operating...

Name: Z-0194-2017 General Pack I, Kit number CMP1811(B convenience custom kits used for general surgery in hospital operating...
Creator: Windstone Medical Packaging, Inc.
Published: 2015-04-22
License: https://open.fda.gov/license/

Windstone Medical Packaging, Inc. / initiated 2015-04-22 / Terminated / root cause: sterility

FDA source

Windstone Medical Packaging, Inc. began a recall of General Pack I, Kit number CMP1811(B convenience custom kits used for general surgery in hospital operating room on 2015-04-22. FDA classified it as Class II and gives the reason as "The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0194-2017
Classification: Class II
Status: Terminated
Initiated: 2015-04-22
Posted: 2016-10-20
Terminated: 2016-10-25
Recalling firm: Windstone Medical Packaging, Inc.
Product: General Pack I, Kit number CMP1811(B convenience custom kits used for general surgery in hospital operating room
Product code: FSY Light, Surgical, Ceiling Mounted
Reason for recall: The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.
Root cause tag: sterility
FDA root cause: Unknown/Undetermined by firm
Action: Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees. Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes. Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution. AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well. Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read: RECALL NOTICE Medtronic announced the recall l of Devon Light Glove contained in this kit after it was sealed and sterilized. All other components in the kit are not affected by this recall. 1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside 2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution. Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875. For any questions about this recall, please call 321-527-7714. For questions regarding this recall call 404-259-6387.
Quantity in commerce: 1596 kits
Distribution: Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
Product codes and lots: Lot Numbers/Expiration Dates: 59313 4/12/2015 59483 7/22/2015 59876 9/13/2015 61092 9/13/2015 60552 10/29/2015 65936 11/2/2015 61362 11/7/2015 62976 11/8/2015 65432 11/8/2015 66398 11/10/2015 61093 11/15/2015 62301 11/18/2015 62676 12/14/2015 64312 1/6/2016 64793 1/12/2016 64183 1/14/2016 63524 1/17/2016 57212 6/16/2016 57213 7/5/2016 67910 7/15/2016 67594 7/27/2016 58074 8/7/2016 58649 8/30/2016 70167 9/15/2016 67911 9/18/2016 68879 10/9/2016 69319 10/31/2016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0194-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0139-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0140-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0141-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0142-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0143-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0144-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0145-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0146-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0147-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0148-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0149-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0150-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0151-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0152-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0153-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0154-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0155-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0156-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0157-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0158-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0159-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0160-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0161-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0162-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0163-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0164-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0165-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0166-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0167-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0168-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0169-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0170-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0171-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0172-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0173-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0174-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0175-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0176-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0177-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0178-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0179-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0180-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0181-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0182-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0183-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0184-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0185-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0186-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0187-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0188-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0189-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0190-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0191-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0192-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0193-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0194-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0195-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0196-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0197-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0198-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0199-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0200-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0201-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0202-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0203-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0204-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0205-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0206-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0207-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0208-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0209-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0210-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0211-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0212-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0213-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0214-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0215-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0216-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0217-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0218-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0219-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0220-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0221-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0222-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0223-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0224-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0225-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0226-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0227-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0228-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0229-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0230-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0231-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0232-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0233-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0234-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0235-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0236-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0237-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0238-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0239-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0240-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0241-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0242-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0243-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0244-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0245-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0246-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0247-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0248-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0249-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0250-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0251-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0252-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0253-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0254-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0255-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0256-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0257-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0258-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0259-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0260-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0261-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0262-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0263-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0264-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0265-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0266-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0267-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0268-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0269-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0270-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0271-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0272-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0273-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0274-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0275-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0276-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0277-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0278-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0279-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0280-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0281-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0282-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0283-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0284-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0285-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0286-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0287-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0288-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20

Product code FSY

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)