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Lower risk Medical device recall · FDA · Published September 1, 2023

American Contract Systems LAVH/REF BBLV21C Recall: Risk of Reduced Drug Efficacy

American Contract Systems recalls LAVH and REF BBLV21C devices due to potential reduced drug efficacy from improper sterilization. Affected units have specific lot numbers and UDI/DI codes.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0172-2024Medical deviceAmerican Contract Systems ›
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Contact the company

Recalling firmAmerican Contract Systems, Inc.7802 E Telecom Pkwy · Temple Terrace, FL 33637-0928
✎ GovInfoNow plain-language explainer

American Contract Systems is recalling LAVH and REF BBL:21C medical devices because components were exposed to higher temperatures and EO gas during sterilization. This could lead to reduced drug effectiveness in treatments. Read more at govinfonow.com/recall/57386-american-contract-systems-lavh-ref-bblv21c-recall-risk-of-reduced.

Source Summary by GovInfoNow · govinfonow.com/recall/57386-american-contract-systems-lavh-ref-bblv21c-recall-risk-of-reduced · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0172-2024

Cite this page

“American Contract Systems LAVH/REF BBLV21C Recall: Risk of Reduced Drug Efficacy.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57386-american-contract-systems-lavh-ref-bblv21c-recall-risk-of-reduced. Based on FDA recall #Z-0172-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0172-2024%22&limit=1).

The FDA announced on September 1, 2023, that American Contract Systems Inc. is recalling LAVH, REF BBLV21C devices due to potential loss of functionality and higher ethylene oxide residuals. The recall involves components inadvertently subjected to the company's sterilization process.

How to tell if you have it

  • Brand: American Contract Systems
  • Product: LAVH, REF BBLV21C
  • UDI/DI: 00191072166234
  • Lot Number: 686221
  • Quantity: 18 cases

The hazard

The I.V. Cath and Adhesive Dermabond components were exposed to ethylene oxide and higher temperatures than approved by the manufacturer, according to the FDA. This may result in a loss or lack of functionality, loss of drug efficacy if applicable, and higher than specified ethylene oxide residuals.

Context

GovInfoNow's records show American Contract Systems Inc has 21 other recalls on record since November 21, 2018. Other recent recalls of similar products include Argon Medical Arterial Line Kit 20ga x 6 Recall (June 1, 2026), Argon Medical Devices Bone Marrow Tray Recall (June 1, 2026) and Argon Medical Devices General Biospy Tray Recall (June 1, 2026).

How to tell if you have this one

Check for the lot number 686221 and UDI/DI code 00191072166234 on the device packaging or label. The product names are LAVH and REF BBLV21C.

  • Brand
    American Contract Systems
  • Category
    Medical device
FDA recall event · 12 products

All 12 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    US Nationwide distribution in the states of FL, IA.
Recall numberProduct, codes & lotsQuantity
Z-0171-2024General Pack, REF BBGP31C; UDI/DI 00191072166609, Lot Number 96823157 cases
Z-0172-2024LAVH, REF BBLV21C; UDI/DI 00191072166234, Lot Number 68622118 cases
Z-0173-2024Breast Plastics Pack, REF BBPL20D; UDI/DI 00191072166241, Lot Numbers: 756221, 782221, 86222120 cases
Z-0174-2024Robotics Pack SAH, REF SAR530M; UDI/DI00191072179678, Lot Numbers: 949231, 98323196 cases
Z-0175-2024CVS PCSU SJH, REF SJCV48J; UDI/DI 00191072167903, Lot Numbers: 945231, 954231, 97423136 cases
Z-0176-2024Pediatric Heart SJH, REF SJPH34K; UDI/DI 00191072167064, Lot Numbers: 97523172 cases
Z-0177-2024Vasc. Open CVOR SJH, REF SJVO56B; UDI/DI 00191072182869, Lot Numbers: 940231, 97423184 cases
Z-0178-2024Robotics Pack, REF SJVO56B; UDI/DI 00191072122339, Lot Numbers: 965231112 cases
Z-0179-2024Robotics Pack, REF SSRO22D; UDI/DI 00191072167705, Lot Numbers: 933231, 98723156 cases
Z-0180-2024Sub Q Recorder Pack, REF BPRC87A; UDI/DI 00191072187970, Lot Numbers: 96923196 cases
Z-0181-2024Pediatric Urology Wolson Pack, REF BPPU55A; UDI/DI 00191072187949, Lot Numbers: 923231, 977231448 cases
Z-0182-2024Cath Cardiac Pack, REF IHCC03V; UDI/DI 00191072189431, Lot Numbers: 724221, 679221, 9452311260 units
Based on the official FDA remedy

What to do — step by step

  1. Check Device Details

    Look for the lot number 686221 and UDI/DI code 00191072166234 on the device packaging or label.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 2 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution in the states of FL, IA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Florida, Iowa.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Sep 1, 202312. FDA classified it Class II: Oct 26, 202323. Published in FDA’s Enforcement Report: Nov 1, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0172-2024 (September 1, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0172-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA