Recall Register

Food, drugs, devices › American Contract Systems, Inc.

Device recall: General Pack, REF BBGP31C

FDA enforcement event 93086 · Class II · initiated 1 Sep 2023 · status Ongoing

DeviceVoluntary: Firm initiated12 product recordsTemple Terrace, FL

FDA enforcement event 93086 is a device recall by American Contract Systems, Inc. of Temple Terrace, FL, initiated 1 Sep 2023 and classified Class II, with 12 product records.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 917 device enforcement events initiated in 2023 carry the same class.

Status: Ongoing. Initiation: voluntary: firm initiated. American Contract Systems, Inc. has 22 enforcement events on this register, with a median of 4 product records per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

American Contract Systems, Inc., Temple Terrace, FL.

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…"

Distribution

"US Nationwide distribution in the states of FL, IA."

Product records

Recall numberProductQuantityClassStatusReport date
Z-0171-2024General Pack, REF BBGP31C57 casesClass IIOngoing1 Nov 2023
Z-0172-2024LAVH, REF BBLV21C18 casesClass IIOngoing1 Nov 2023
Z-0173-2024Breast Plastics Pack, REF BBPL20D20 casesClass IIOngoing1 Nov 2023
Z-0174-2024Robotics Pack SAH, REF SAR530M96 casesClass IIOngoing1 Nov 2023
Z-0175-2024CVS PCSU SJH, REF SJCV48J36 casesClass IIOngoing1 Nov 2023
Z-0176-2024Pediatric Heart SJH, REF SJPH34K72 casesClass IIOngoing1 Nov 2023
Z-0177-2024Vasc. Open CVOR SJH, REF SJVO56B84 casesClass IIOngoing1 Nov 2023
Z-0178-2024Robotics Pack, REF SJVO56B112 casesClass IIOngoing1 Nov 2023
Z-0179-2024Robotics Pack, REF SSRO22D56 casesClass IIOngoing1 Nov 2023
Z-0180-2024Sub Q Recorder Pack, REF BPRC87A96 casesClass IIOngoing1 Nov 2023
Z-0181-2024Pediatric Urology Wolson Pack, REF BPPU55A448 casesClass IIOngoing1 Nov 2023
Z-0182-2024Cath Cardiac Pack, REF IHCC03V1260 unitsClass IIOngoing1 Nov 2023

Context

88%of 2023 device events are Class II917 events that year
12product records in this eventfirm median: 4
22events on this register for the firm

Other enforcement events for American Contract Systems, Inc.

InitiatedProduct (first record)TypeClassRecords
29 Jun 2026American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AMDeviceClass II4
19 May 2026American Contract Systems medical procedure kits and trays labeled as: 1) CRANI PACK - 208400, Model Item Number UDCP57ADeviceClass II2
19 Mar 2026Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model DeviceClass I1
4 Sep 2025Basic Biopsy Tray, Item Number NMBP44LDeviceClass II18
14 Jul 2025AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCV78DeviceClass II9
21 Apr 2025LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK, Model: NCTK31K; TOTAL KNEE PACK, ModeDeviceClass II1
6 Feb 2025LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41GDeviceClass II32
4 Feb 2025CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.DeviceClass II1
31 Jan 2025Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: ConveniencDeviceClass II3
7 Aug 2024PACEMAKER PACK, SLCV01J; Medical convenience kitDeviceClass II19

All 22 events for American Contract Systems, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall 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 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…"

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "US Nationwide distribution in the states of FL, IA."

Is the recall still ongoing?

FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.