Z-2088-2023Class II

Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGIO PACK, REF...

Name: Z-2088-2023 Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGIO PACK, REF...
Creator: DeRoyal Industries Inc
Published: 2023-05-30
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2023-05-30 / Open, Classified / root cause: manufacturing process

FDA source

DeRoyal Industries Inc began a recall of Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGIO PACK, REF 89-10901 c) BASIN, REF 89-1924 d) CYSTO PACK, REF... on 2023-05-30. FDA classified it as Class II and gives the reason as "The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside". 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-2088-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-30
Posted: 2023-07-03
Recalling firm: DeRoyal Industries, Inc.
Product: Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGIO PACK, REF 89-10901 c) BASIN, REF 89-1924 d) CYSTO PACK, REF 89-7133 e) TOTAL HIP PACK, REF 89-9134 f) EMERGENCY C-SECTION PACK, REF 89-9478
Product code: KDD Kit, Surgical Instrument, Disposable
Reason for recall: The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: DeRoyal disseminated an URGENT! DEROYAL RECALL NOTICE to its consignees on 05/30/2023 by email. The notice explained the issue, the risk, and requested the return of the affected products. Distributors were also directed to identify and notify their customers.
Quantity in commerce: 328 packs
Distribution: US Nationwide distribution.
Product codes and lots: a) REF 89-10640, GTIN 50749756367740 (cs), 00749756367745 (unit), Lot Numbers: 58737945; b) REF 89-10901, GTIN 50749756380244 (cs), 00749756380249 (unit), Lot Numbers: 58820749; c) REF 89-1924, GTIN 50749756216864 (cs), 00749756216869 (unit), Lot Numbers: 58746227; d) REF 89-7133, GTIN 50749756736744 (cs), 00749756736749 (unit), Lot Numbers: 58789323; e) REF 89-9134, GTIN 50749756911332 (cs), 00749756911337 (unit), Lot Numbers: 58701336; f) REF 89-9478, GTIN 50749756926909 (cs), 00749756926904 (unit), Lot Numbers: 58738454

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2088-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2086-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-03
Z-2087-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-03
Z-2088-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-03
Z-2089-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-03
Z-2090-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-03

Product code KDD

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)