Z-1638-2013Class II

- Calf Garment Standard Ref. L501-M Lot 122549, 122985 - Calf Garment, DVT10 Standard Ref. DVT10 Lot 122570...

Name: Z-1638-2013 - Calf Garment Standard Ref. L501-M Lot 122549, 122985 - Calf Garment, DVT10 Standard Ref. DVT10 Lot 122570...
Creator: Surgical Instrument Service And Savings, Inc.
Published: 2013-05-03
License: https://open.fda.gov/license/

Medline ReNewal / initiated 2013-05-03 / Terminated / root cause: packaging

FDA source

Surgical Instrument Service And Savings, Inc. began a recall of - Calf Garment Standard Ref. L501-M Lot 122549, 122985 - Calf Garment, DVT10 Standard Ref. DVT10 Lot 122570, 12546 - Calf Garment, DVT20 Large Ref. DVT20 Lot... on 2013-05-03. FDA classified it as Class II and gives the reason as "The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch". 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-1638-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-03
Posted: 2013-07-01
Terminated: 2013-07-11
Recalling firm: Medline ReNewal
Product: - Calf Garment Standard Ref. L501-M Lot 122549, 122985 - Calf Garment, DVT10 Standard Ref. DVT10 Lot 122570, 12546 - Calf Garment, DVT20 Large Ref. DVT20 Lot 122549, 122570 - SCD Express Compression Sleeve, Knee Length, (White) Large Ref. 9789 Lot 122574 - SCD Express Compression Sleeve, Knee Length, (White) Medium Ref. 9529 Lot 122547, 122574 - SCD Express Compression Sleeve, Thigh Length, (White) Medium Ref. 9530 Lot 122574 Compressible limb sleeve. - Thigh Garment DVT30 Medium Ref. DVT30 Lot 122549, 122985 - Thigh Garment DVT40 Large Ref. DVT40 Lot 122549, 122985 - Vaso-Force Intermittent DVT Calf Garment, Large, Calf Sizes up to 24" 24" Ref. MDS601L Lot 122982, 122986 - Vaso-Force Intermittent DVT Calf Garment, Medium, Calf Sizes up to 18" 18" Ref. MDS601M Lot 122986, 122984 - VENAFLOW Calf Cuff, w/Foam (White) 19" Max. Calf Circumference Ref. 3010-PL Lot 122692, 122715
Product code: JOW Sleeve, Limb, Compressible
Reason for recall: The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: MEDISISS sent a Correction Immediate Action Request letter dated May 2, 2013, to all affected customes. The letter identified the product, the problem, and the action to be taken by the customer. The letter directed the customer to inspect the products prior to use for seal integrity as specified on the product labeling: "Sterile unless package has been damaged or opened. Do not use if package is damaged." This will be followed up by a visit from the customer's sales representatives who are tasked with inspecting all the lots that may be remaining in the customer's inventory. The sales representative is directed to complete a "Verification of Seal Inspection" form and return it to MEDISISS Customer Relations. Devices with unacceptable seals are to be returned to MEDISISS. The sales representative is responsible for obtaining a shipping label from customer service to enable the devices to be returned to the recalling firm via Fed Ex. Customers with questions were instructed to call 866-866-7477.
Quantity in commerce: 229
Distribution: Nationwide Distribution.
Product codes and lots: 122692, 122982, 122986, 122984, 122549, 122985, 122570, 122546, 122547, 122574, 122715.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1638-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1623-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1624-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1625-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1626-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1627-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1628-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1629-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1630-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1631-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1632-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1633-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1634-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1635-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1636-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1637-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1638-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1639-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1640-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1641-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1642-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1643-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1644-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01

Product code JOW

K012658Class IIReprocessed Compression Limb SleevesSurgical Instruments Service and Savings, Inc. / cleared 2002-05-14

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)