FDA-Device2026-09-23Class IIPACKAGING DEFECT

Medline anesthesia pain relief kits recalled for open sterile pouch seals

OTHERNationwide distributionMedical devices

What this means

Medline Industries anesthesia pain relief convenience kits may have open seals in their sterile pouch packaging. An open seal can allow bacteria or other contaminants to enter the package, potentially compromising the sterility of the medical supplies inside. If used without noticing the damaged seal, these kits could introduce infection into the surgical field or patient.

  • Check all Medline anesthesia pain kits (DYNJ67925A, Lot 25BBK494) before opening or using.
  • Do not use any kit with a visibly open, torn, or compromised seal.
  • Contact your supplier or Medline Industries for replacement or instructions on affected units.
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The agency's original wording
Hazard

Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.

Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in states of Arkansas, Florida, North Carolina, Maryland, and Texas.
Affected count
341
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3207-2026

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