American Contract Systems, Inc. recalls LAVH, REF BBLV21C
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…
Read the official notice →- Date
- 2023-11-01
- Country
- United States
- Brand
- American Contract Systems
- Product
- LAVH, REF BBLV21C
- Classification
- Class II
- Units
- US Nationwide distribution in the states of FL, IA.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
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- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More American Contract Systems recalls
- 2024-08-14
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Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber
FDA · DeviceAmerican Contract Systems, Inc.US Nationwide distribution in the states of CA, KS, ME, MN, MO, NE, and SD.Official notice →- 2024-07-17
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American Contract Systems Inc recalls TOTAL KNEE - 302497- Procedure tray Catalog Number: ANTK12AF
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- 2024-02-07
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American Contract Systems, Inc. recalls Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IMPLANT PACK, kit number AGBI64J; b) LAB DEVICE…
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked"…
- 2023-06-21
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American Contract Systems, Inc. recalls Total Knee Pack, REF CETJ130, medical convenience kits
Incorrect expiration date on product.
- 2022-11-30
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American Contract Systems, Inc. recalls BASIN SET, MEBS42K, general surgical kit
Basin Set labeling error: components within the kit are for the Single Basin Set. Therefore, the contents of the package do not match the contents listed on the label.
- 2022-10-19
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American Contract Systems, Inc. recalls COVID Test Kit Nonsterile
Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 device.
Other drugs & medical recalls in the United States
- 2023-11-08
- US
- US
GlaxoSmithKline Consumer Healthcare Holdings LLC recalls TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 72-count…
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
FDA · DrugGlaxoSmithKline Consumer Healthcare Holdings LLCNationwide within the United StatesOfficial notice → - 2023-11-01
- US
Carl Zeiss Suzhou Co., Ltd. recalls OPMI LUMERA 300, REF 6137
Surgical microscope for use in ophthalmology may be missing a screw from the suspension arm, which may cause the suspended components to fall from the suspension arm, which may injure any person under the suspended…
FDA · DeviceCarl Zeiss Suzhou Co., Ltd.US Nationwide distribution in the states of MD, TX, CA, GA, LA.Official notice → - US
Medtronic Sofamor Danek USA Inc recalls Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix
Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have…
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EMPATICA SRL recalls Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities…
May have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequently.
FDA · DeviceEMPATICA SRLWorldwide distribution - US Nationwide and the countries of Italy, Ireland,…Official notice → - US
Smith & Nephew, Inc. recalls JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and…
FDA · DeviceSmith & Nephew, Inc.Worldwide distribution - US Nationwide and the country of Japan.Official notice →