Z-1985-2019Class II

Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in...

Name: Z-1985-2019 Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in...
Creator: Djo, Llc
Published: 2019-01-17
License: https://open.fda.gov/license/

DJO, LLC / initiated 2019-01-17 / Open, Classified / root cause: manufacturing process

FDA source

DJO, LLC began a recall of Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC on 2019-01-17. FDA classified it as Class II and gives the reason as "The product may not meet sterility requirements. Product labeled as sterile, however all units do not appear to meet sterility requirements". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1985-2019
Classification: Class II
Status: Open, Classified
Initiated: 2019-01-17
Posted: 2019-07-18
Recalling firm: DJO, LLC
Product: Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC.
Product code: JOW Sleeve, Limb, Compressible
Reason for recall: The product may not meet sterility requirements. Product labeled as sterile, however all units do not appear to meet sterility requirements.
Root cause tag: manufacturing process
FDA root cause: Environmental control
Action: On January 18, 2019 a Urgent: Medical Device Recall letter was sent via email to customers. The letter ask all customers to send the notification to all customers who have purchased or were issued the affected product. In addition, the letter request that the customer complete the "Return Response" form by February 15, 2019. If you have any additional questions, please contact the firm at 1-800-321-9549.
Quantity in commerce: 9 units
Distribution: Distributed domestically, Oklahoma
Product codes and lots: Lot # 418003 UDI: (01)00888912302418

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1985-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1985-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-07-24	2019-07-18

Product code JOW

K964238Class IIAircast Vena Flow Sterile Disposable CuffsAircast, Inc. / cleared 1997-09-08

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)