Recall Z-1791-2022— Mckesson Medical-Surgical Inc. Corporate Office

Name: FDA recall Z-1791-2022
Creator: U.S. Food and Drug Administration
Published: 2022-05-25

Class III · Ongoing

Class III FDA medical device recall by Mckesson Medical-Surgical Inc. Corporate Office, initiated 2022-05-25. It names one FDA 510(k) clearance: K941327. Product: 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: SCT3.. Reason: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21..

Recalling firm: Mckesson Medical-Surgical Inc. Corporate Office
Classification: Class III
Status: Ongoing
Initiated: 2022-05-25
Firm location: Richmond, VA, United States

510(k) clearances named in this recall

1 on FDA's record

K941327 — CROSSTEX SELF-SEALING STERILIZATION POUCHCross Country Paper Products Corp.·cleared 1994-12-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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: SCT3.

Reason for recall

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

Data sourced from openFDA. This site is unofficial and independent of the FDA.