O&M HALYARD, INC. is recalling approximately 1,440 HALYARD Laparotomy Packs because elevated residues of a manufacturing additive were found within the sterile packaging. This additive residue could compromise the sterile field during surgical procedures. No incidents or injuries have been reported in connection with this issue, but the manufacturer has initiated this voluntary recall to ensure patient safety. Healthcare providers and surgical centers should stop using the affected packs immediately.
The manufacturing additive residue inside the sterile packaging may contaminate the surgical pack. This poses a risk of introducing non-sterile material into a surgical site during a laparotomy procedure, which could lead to infections or other medical complications for the patient.
Manufacturer: O&M HALYARD, INC.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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