The Recall Desk
HighFDA (Devices)·Z-0902-2022·Announced 2022-04-20

Cardinal Health Surgical Gloves Recalled for Lack of Sterilization

Cardinal Health PROTEXIS PI and PI Classic surgical gloves were distributed without proper sterilization. The affected 486,578 pairs should not be used, as non-sterile gloves present an infection risk during surgical procedures.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall for failure to sterilize surgical gloves, a critical safety requirement. No illnesses or injuries have been reported, but the defect presents a risk of infection in surgical procedures, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Cardinal Health PROTEXIS PI and PI Classic surgical gloves, totaling 486,578 pairs, have been recalled because the product was distributed without being sterilized. Sterilization is a critical requirement for surgical gloves, as they are used in medical procedures where maintaining a sterile field is essential to patient safety.

The affected gloves were distributed throughout the United States and Guam. Specific lot information includes Catalog Numbers 2D72PL65X (Lot TS21050195, Expiration 04/30/2024) and 2D72PT65X (Lot TS21050215, Expiration 04/30/2024), along with corresponding UDI codes on ship cases, dispenser cartons, and individual units.

Healthcare facilities and users of these gloves should immediately stop using the affected product and contact Cardinal Health 200, LLC for return or replacement information. Non-sterile gloves pose a risk of patient infection if used in surgical procedures.

The recalled product

Product
Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves
Manufacturer
Cardinal Health 200, LLC
Category
Medical Device — Surgical Gloves
Hazard
  • non-sterile
  • infection-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

  • Catalog Numbers: 1) 2D72PL65X
  • Lot Number TS21050195
  • EXP 04/30/2024 - UDI on ship case: 50885380031760
  • UDI on Dispenser carton: 20885380031769
  • UDI on individual unit: 10885380031762 2) 2D72PT65X
  • Lot Number TS21050215
  • EXP 04/30/2024 - UDI on ship case: 50885380031937
  • UDI on Dispenser carton: 20885380031936
  • UDI on individual unit: 10885380031939

Distribution

Distribution scope not specified by the agency.

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