Z-0221-2018Class II

Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 16CM (0.021), REF/Product Code...

Name: Z-0221-2018 Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 16CM (0.021), REF/Product Code...
Creator: Terumo Medical Corp
Published: 2017-06-07
License: https://open.fda.gov/license/

Terumo Medical Corp. / initiated 2017-06-07 / Terminated / root cause: manufacturing process

FDA source

Terumo Medical Corp began a recall of Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 16CM (0.021), REF/Product Code RM*ES6F16HAU, STERILE, Rx ONLY on 2017-06-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0221-2018
Classification: Class II
Status: Terminated
Initiated: 2017-06-07
Posted: 2017-12-08
Terminated: 2019-04-25
Recalling firm: Terumo Medical Corp.
Product: Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 16CM (0.021), REF/Product Code RM*ES6F16HAU, STERILE, Rx ONLY
Product code: DYB Introducer, Catheter
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Distribution: Nationwide and Canada
Product codes and lots: Lot s 161209, 170118, 170215, 170317

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0221-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0214-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-08
Z-0215-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-08
Z-0216-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-08
Z-0217-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-08
Z-0218-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-08
Z-0219-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-08
Z-0220-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-08
Z-0221-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-08
Z-0222-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-08
Z-0223-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-08
Z-0224-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-08
Z-0225-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-08
Z-0226-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-08
Z-0227-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-08
Z-0228-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-08
Z-0229-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-08
Z-0230-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-08

Product code DYB

K142183Class IIGlidesheath SlenderTerumo Medical Corporation / cleared 2014-11-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)