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Terminated

Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 16CM (0.021), REF/Product Code RM*ES5F16HAU, STERILE, Rx ONLY

FDA Recall Z-0218-2018 · Posted None

Recalling FirmTerumo Medical Corp
Recall StatusTerminated
Product CodeDYB
Date Initiated2017-06-07
Date Terminated2019-04-25

Reason for Recall

An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.

Firm Action

URGENT VOLUNTARY MEDICAL DEVICE RECALL Letters (dated June 7, 2017) and Response Forms were sent to the consignees via UPS on June 7, 2017.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide and Canada

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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