Z-0180-2024Class II

Sub Q Recorder Pack, REF BPRC87A

Name: Z-0180-2024 Sub Q Recorder Pack, REF BPRC87A
Creator: American Contract Systems, Inc.
Published: 2023-09-01
License: https://open.fda.gov/license/

American Contract Systems, Inc. / initiated 2023-09-01 / Open, Classified / root cause: manufacturing process

FDA source

American Contract Systems, Inc. began a recall of Sub Q Recorder Pack, REF BPRC87A on 2023-09-01. FDA classified it as Class II and gives the reason as "During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and...". 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-0180-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-01
Posted: 2023-10-26
Recalling firm: American Contract Systems, Inc.
Product: Sub Q Recorder Pack, REF BPRC87A
Product code: OES Cardiac Catheterization Kit
Reason for recall: During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Owens & Minor issued an URGENT: MEDICAL DEVICE FIELD CORRECTION to its consignees on 09/01/2023 by email. The notice explained the issue, risk, and requested the user discontinue the use of the I.V. Cath and Adhesive Dermabond and affix a warning label to each kit and case of affected product in inventory. The firm sent an updated letter on 09/22/2023 via email which corrected the product distribution date.
Quantity in commerce: 96 cases
Distribution: US Nationwide distribution in the states of FL, IA.
Product codes and lots: UDI/DI 00191072187970, Lot Numbers: 969231

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0180-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0171-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-26
Z-0172-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-26
Z-0173-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-26
Z-0174-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-26
Z-0175-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-26
Z-0176-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-26
Z-0177-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-26
Z-0178-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-26
Z-0179-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-26
Z-0180-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-26
Z-0181-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-26
Z-0182-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-26

Product code OES

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)