Z-0162-2018Class II

Sensicare Green Surgical Glove, PI, LF, PF. Packaged in a poly/poly peel pouch with Sunoco films, sterile...

Name: Z-0162-2018 Sensicare Green Surgical Glove, PI, LF, PF. Packaged in a poly/poly peel pouch with Sunoco films, sterile...
Creator: Medline Industries Inc
Published: 2017-10-23
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2017-10-23 / Terminated / root cause: packaging

FDA source

Medline Industries Inc began a recall of Sensicare Green Surgical Glove, PI, LF, PF. Packaged in a poly/poly peel pouch with Sunoco films, sterile. Surgical glove on 2017-10-23. FDA classified it as Class II and gives the reason as "Possible open seal on top portion of the package. Could cause breach of sterility". 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-0162-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-23
Posted: 2017-11-21
Terminated: 2021-04-06
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Sensicare Green Surgical Glove, PI, LF, PF. Packaged in a poly/poly peel pouch with Sunoco films, sterile. Surgical glove.
Product code: KGO Surgeon'S Gloves
Reason for recall: Possible open seal on top portion of the package. Could cause breach of sterility.
Root cause tag: packaging
FDA root cause: Packaging
Action: Medline Industries sent an Immediate Action Required Letter dated October 23, 2017, to all affected customers.. Instructions included to check inventory and quarantine affected product, complete and return the response form to Medline, arrange for the return of any affected product, and notify any customers if the product was further distributed. Customers with questions were instructed to call 866-359-1704.
Quantity in commerce: 8,000 units
Distribution: Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Internationally to Canada.
Product codes and lots: Model No. MSG1285, Lot No. 701893369485

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0162-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0162-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-21

Product code KGO

K040503Class IAloetouch Powder Free, Polymer Coated Polyisoprene Surgical Gloves, Sterile, Coated with Aloe Vera, Natural ColourWrp Asia Pacific Sdn. Bhd. / cleared 2004-03-16

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)