McKesson 73-SSP382Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20612479159369), received between Oct 6, 2022 and Oct 6, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K941327); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 6, 2022Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED THAT THERE WERE HOLES IN THEIR MCKESSON SELF-SEAL POUCHES AND THE INSTRUMENTS STERILIZED IN THE POUCHES WERE SUBSEQUENTLY USED DURING PATIENT PROCEDURES. THE NUMBER OF DEVICES USED IS UNKNOWN. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15551079 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K941327. One submission often covers many models, so check the product and lot details in each record.

• Z-1791-2022 · May 25, 2022 · Open, Classified
  SPS MEDICAL SUPPLY Crosstex International Sterilization Roll Sani-Roll Ethylene Oxide (EO) Gas / Steam 3 Inch X 100 Foot Transparent / Blue Self Seal Paper / Film Model Number: SCT