Volcano SpinVision Sterile Equip cover II; Sterile; General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be used in the sterile surgical field but cannot be sterilized. The sterile drapes are put over this equipment in case any sterile items may come into contact with them.
FDA Recall Z-1042-2016 · Posted 2016-03-03
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Recalling FirmVolcano Corporation
Recall StatusTerminated
Product CodeKKX
Date Initiated2016-02-05
Date Terminated2017-03-21
Product Quantity1355 total
Reason for Recall
Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Covers may have the incorrect expiry date on the outer shipping box; individually wrapped inner product bears the correct expiry date.
Firm Action
Urgent Medical Device letters were sent to affected consignees the week of February 8, 2016 by Fed Ex or UPS so delivery can be tracked. For OUS consignees, the same letter will be sent and they will execute delivery to customers and track responses.
Root Cause
Labeling False and Misleading
Distribution Pattern
Distributed US (nationwide) and the countries of Australia, South Africa, Canada, New Zealand, Belgium, Japan, and Paraguay.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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