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McKesson
MCKESSON MEDICAL-SURGICAL INC. · Model 183-i80-09178-S · UDI-DI 10612479230320
10
510(k) clearances
803
Adverse events (10 deaths)
91
Recalls
223
Facilities
Description
U-Drape 2.5 IN x 37 IN SPILT 76 in x 110 in
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-27 | Medline Industries, LP | Unapproved design changes to the products outside of the 510(k) clearance. |
| 2026-01-07 | Medline Industries, LP | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag |
| 2026-01-07 | Medline Industries, LP | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag |
| 2025-07-17 | O&M HALYARD INC | Surgical drape packs may have open seals, which may compromise the sterility of the product. |
| 2025-03-03 | MEDLINE INDUSTRIES, LP - Northfield | There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2024-11-26 | O&M HALYARD, INC. | Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging. |
| 2024-09-04 | MEDLINE INDUSTRIES, LP - Northfield | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal |
| 2024-04-08 | MEDLINE INDUSTRIES, LP - Northfield | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma |
| 2023-05-15 | MEDLINE INDUSTRIES, LP - Northfield | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2022-12-07 | MEDLINE INDUSTRIES, LP - Northfield | The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.