Non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are nitrile, powder-free, ambidextrous, and blue-colored with a beaded cuff. The range of sizes includes small, medium, large, and extra-large.
This recall is currently active, issued July 9, 2024. It was issued by Svs Llc.
- Company
- Svs Llc
- Recall Initiated
- May 13, 2024
- Posted
- July 9, 2024
- Recall Number
- Z-2320-2024
- Quantity
- 155,540 inner boxes
- Firm Location
- Charlotte, NC
- Official Source
- View on FDA website ↗
Reason for Recall
Firm received complaints regarding skin irritation when using the gloves, disintegration of the gloves when used with certain cleaning solutions, and mislabeled products (e.g., outer box indicating one size, but inner box indicating another size).
Distribution
US Nationwide distribution in the states of MI, NE, FL, GA, PA, AR, CO, and NY.
Lot / Code Info
Item Numbers: size XS - D5061/lot number: AEAM1105/UDI: 00811220035433; size S - D5062/lot number: AEAM1103,AEAM1104,AEAM1105,AEAM1106,AEAN0204,AEAN0205,AEAN0206,AEAN0307,AEAN0308,AEAN0309,AEAN0310,AEAN0311,AEAN0312,AEAN0316,AEAN0317,AEAN0318/ UDI: 00811220035440; size M - D5063/lot number: AEAM1104,AEAM1105,AEAM1112,AEAN0204,AEAN0205,AEAN0206,AEAN0307,AEAN0308,AEAN0309,AEAN0311,AEAN0312,AEAN0316,AEAN0317,AEAN0318,AEAN0319,AEAN0320,AEAN0206/UDI: 00811220035457; size L - D5064/lot number: AEAM1103,AEAM1104,AEAM1106,AEAN0204,AEAN0205,AEAN0206,AEAN0307,AEAN0308,AEAN0309,AEAN0310,AEAN0311,AEAN0312,AEAN0317,AEAN0318,AEAN0319,AEAN0320/UDI: 00811220035464; and size XL D5065/lot number: AEAN0204,AEAN0205,AEAN0206,AEAN0308,AEAN0310,AEAN0311/UDI: 00811220035471
Root Cause
Under Investigation by firm
Action Taken
Consignees were notified via email on 05/13/2024. The consignees are instructed to discontinue using PremierPro PlusTM D506X series exam gloves; Notify end-users of this voluntary recall notification and discontinue use of the products within your healthcare facilities; Remove these products from areas where they may be available including all points of care, supply part locations, and central supply warehouses; Return the products within Table A above to the firm at the firm's expense. All returns of the above-listed products will be replaced by S2S Global with internationally-sourced PremierProTM 506x gloves unless the consignee indicates a different preference; Continue reporting any and all issues that may arise with the use of domestically-sourced PremierPro PlusTM D506X series exam gloves to S2S Global; and " Return the completed Medical Device Recall Return Response Acknowledgement and Receipt Form located in Appendix A below to S2S Global.