Z-0863-2022Class II

Lum Lam Custom Pack - Anesthesia Kit

Name: Z-0863-2022 Lum Lam Custom Pack - Anesthesia Kit
Creator: Stradis Medical, LLC dba Stradis Healthcare
Published: 2022-02-25
License: https://open.fda.gov/license/

Gyn-Disposables, Inc. / initiated 2022-02-25 / Open, Classified / root cause: sterility

FDA source

Stradis Medical, LLC dba Stradis Healthcare began a recall of Lum Lam Custom Pack - Anesthesia Kit on 2022-02-25. FDA classified it as Class II and gives the reason as "The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0863-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-02-25
Posted: 2022-04-04
Recalling firm: Gyn-Disposables, Inc.
Product: Lum Lam Custom Pack - Anesthesia Kit
Product code: OFQ Anesthesia Kit
Reason for recall: The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
Root cause tag: sterility
FDA root cause: Process change control
Action: A copy of the final recall letter was sent to all affected consignees via 1st class USPS mail on February 25, 2022. The consignees were instructed that the use of further distribution of the potentially perforated kits should immediately cease. Instructions were provided to return any unused Surgical Kits with the scope of this recall to Stradis Healthcare s facility in Georgia. Periodic effectiveness checks will be conducted in order to follow-up with consignees to ensure effectiveness.
Quantity in commerce: 21 units
Distribution: US Nationwide distribution in the states of IN, TX, and PA.
Product codes and lots: SKU/Part Number 570-2674; UDI H65257026741 Lot Numbers: 21300478831 and 21314479685

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0863-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0862-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-13	2022-04-04
Z-0863-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-13	2022-04-04
Z-0864-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-13	2022-04-04
Z-0865-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-13	2022-04-04
Z-0866-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-13	2022-04-04

Product code OFQ

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