Z-0272-2018Class II

3040-VenaFlow Calf Garment (Aircast) Quick Connect was mislabeled as 3010-PL Aircast Pos-Lock Connector...

Name: Z-0272-2018 3040-VenaFlow Calf Garment (Aircast) Quick Connect was mislabeled as 3010-PL Aircast Pos-Lock Connector...
Creator: Stryker Sustainability Solutions
Published: 2017-12-01
License: https://open.fda.gov/license/

Stryker Sustainability Solutions / initiated 2017-12-01 / Terminated / root cause: packaging

FDA source

Stryker Sustainability Solutions began a recall of 3040-VenaFlow Calf Garment (Aircast) Quick Connect was mislabeled as 3010-PL Aircast Pos-Lock Connector. Intended for use in preventing deep vein thrombosis... on 2017-12-01. FDA classified it as Class II and gives the reason as "3040 compression sleeves being mislabeled as a 3010-PL compression sleeves". 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-0272-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-01
Posted: 2017-12-21
Terminated: 2018-09-27
Recalling firm: Stryker Sustainability Solutions
Product: 3040-VenaFlow Calf Garment (Aircast) Quick Connect was mislabeled as 3010-PL Aircast Pos-Lock Connector. Intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing blood circulation and reducing wound healing time on the calf.
Product code: JOW Sleeve, Limb, Compressible
Reason for recall: 3040 compression sleeves being mislabeled as a 3010-PL compression sleeves.
Root cause tag: packaging
FDA root cause: Packaging
Action: An Urgent Medical Device Recall letter, dated December 5, 2017, was distributed to customers. The letter described the affected product and stated the reason for the recall, as well as the risk to health. Customers were instructed to discontinue use of the affected device ,and complete and return the recall effectiveness check form. All affected product should be returned per the instructions provided and a credit will be issued.
Quantity in commerce: 280 devices
Distribution: Distributed to Texas.
Product codes and lots: Lot 6285035. UDI: 00885825016661.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0272-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0272-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-27	2017-12-21

Product code JOW

K012403Class IIVanguard Reprocessed Compression GarmentVanguard Medical Concepts, Inc. / cleared 2001-10-17

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)