FDA-Device2021-08-25Class II

WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W

Delta Med SpA
Hazard

Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

Sold states
US Nationwide distribution in the states of FL and MN.
Affected count
40,000 units
Manufactured in
Via Guido Rossa 20, N/A, Viadana, N/A, Italy
Products
WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2305-2021

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