CLASS II Device recall · Reported 20 Dec 2017 · FDA Enforcement Report
Glidesheath Slender Hydrophilic Coated Introducer Sheath - (0.021) recalled
Terumo Medical is recalling Glidesheath Slender Hydrophilic Coated Introducer Sheath - (0.021), distributed nationwide in the US. The recall was initiated on 7 Jun 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0223-2018
- FDA event ID
- 77661
- Recalling firm
- Terumo Medical, Somerset, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Jun 2017
- FDA classified
- 8 Dec 2017
- Reported
- 20 Dec 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 7 Jun 2017 | Recall initiated by company | |
| 8 Dec 2017 | Classified by FDA | +184 days |
| 20 Dec 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*RS5F10PA, STERILE, Rx ONLY
Where it was distributed
Nationwide and Canada
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot s 161019, 161115, 161212, 170112
Where was it sold?
Nationwide and Canada
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
16 other products · FDA event 77661This product is part of a recall event; the main page for the event is Glidesheath Slender Hydrophilic Coated Introducer Sheath - (0.021) recalled.
More recalls from Terumo Medical
All 39| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Glidesheath Slender A-kit 6f .021gw recalled by Terumo Medical | Terumo Medical | Packaging Defects | Nationwide |
| Device | CLASS II | Terumo Sur-vet Needle, Product recalled by Terumo Medical | Terumo Medical | Sterility | 12 states |
| Device | CLASS II | Terumo Sur-vet Needle, Product recalled by Terumo Medical | Terumo Medical | Sterility | 12 states |
| Device | CLASS II | Terumo Needle, Product recalled by Terumo Medical | Terumo Medical | Sterility | 12 states |
| Device | CLASS II | Terumo Needle, Product recalled by Terumo Medical | Terumo Medical | Sterility | 12 states |
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| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |