Non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent

FDA device recall Z-2320-2024 · posted 2024-07-09 · Open, Classified

Recall details

Recalling firm

SVS LLC

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).

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

LZC

Quantity affected

155,540 inner boxes

Distribution

US Nationwide distribution in the states of MI, NE, FL, GA, PA, AR, CO, and NY.

Date initiated

2024-05-13

Date posted

2024-07-09

Location

Charlotte, NC

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