JosNoe Medical, Inc. recalls PS-500 Scope Warmer; 10 units per box. Pre-heating scope for laparoscopy surgery.
- Recall date
- December 1, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0732-2016
- FDA classification
- Class II
- Brand / firm
- JosNoe Medical, Inc.
- Sold / distributed
- Distributed US (nationwide) and in Canada.
Why it was recalled
Damage to package seals potentially compromising sterility.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
PS-500 Scope Warmer; 10 units per box. Pre-heating scope for laparoscopy surgery.
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