American Contract Systems recalls two medical devices due to potential over-sterilization with EO gas, risking tissue damage. Affected units have specific model and lot numbers.
Product was sterilized with a higher than specification EO concentration.
American Contract Systems is recalling two medical devices: the Spine Pack and Lumbar/Back Set Up Tray. The recall is due to a risk of tissue damage from excessive sterilization with ethylene oxide gas.
The devices were sterilized with a higher than specified concentration of ethylene oxide gas. This can cause tissue damage if the devices are used after sterilization without proper validation.
Healthcare professionals using these devices in medical settings are most at risk. Patients receiving treatment with these devices may also be affected.
Check for model numbers: LOSP35D for Spine Pack or SALB85AG for Lumbar/Back Set Up Tray. Lot numbers 966221 or 973221 are also indicators of affected units.
Identify the model and lot number to confirm if your device is affected.
The devices were sterilized with a higher than specified concentration of ethylene oxide gas, which can cause tissue damage.
Check for model numbers: LOSP35D (Spine Pack) or SALB85AG (Lumbar/Back Set Up Tray) with lot numbers 966221 or 973221.
The recall does not specify a remedy, so contact American Contract Systems for further instructions.
We’ve drafted a message you can send American Contract Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-1036-2022 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-1036-2022 from American Contract Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
