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SKYN

SURETEX LIMITED - BRANCH · Model 0102 · UDI-DI 00070907001028

MOL

510(k) clearances

Adverse events

Recalls

Facilities

Description

SKYN Classic Pack 2CT (SKYN ORIGINAL)

Recalls

Date	Firm	Reason
2022-06-23	Family Dollar Stores, Llc.	Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
2018-12-19	Reckitt Benckiser LLC	Five batches of the product have failed the specification of 1.0kPa for Burst Pressure.
2018-12-19	Reckitt Benckiser LLC	Five batches of the product have failed the specification of 1.0kPa for Burst Pressure.
2018-08-06	Reckitt Benckiser LLC	Product marketed in U.S. does not have sufficient data to ensure that it will meet the internal burst pressure specifications at the end of 5 yrs shelf-life
2018-07-23	Reckitt Benckiser LLC	The products failed the filed specification of 1.0kPa for Burst Pressure.

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Data 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.