Z-1180-2016Class II

Quick Connects. Steris Corporation. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT. Each Quick...

Name: Z-1180-2016 Quick Connects. Steris Corporation. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT. Each Quick...
Creator: Steris Corporation
Published: 2015-12-04
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2015-12-04 / Terminated / root cause: manufacturing process

FDA source

Steris Corporation began a recall of Quick Connects. Steris Corporation. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT. Each Quick Connect contains a flow unit consisting of... on 2015-12-04. FDA classified it as Class II and gives the reason as "The firm discovered that one of the hysteroscope models listed for processing in four existing Quick Connects has one inlet port rather than two inlet ports as indicated in the Quick Connect processing instructions". 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-1180-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-04
Posted: 2016-03-16
Terminated: 2016-08-26
Recalling firm: STERIS Corporation
Product: Quick Connects. Steris Corporation. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT. Each Quick Connect contains a flow unit consisting of tubing, tethers, and adapters. For sterilant and rinse water used in endoscope washers.
Product code: MED Sterilant, Medical Devices
Reason for recall: The firm discovered that one of the hysteroscope models listed for processing in four existing Quick Connects has one inlet port rather than two inlet ports as indicated in the Quick Connect processing instructions.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 1/18/2016 the firm sent Voluntary Field Correction NOtices to their customers.
Quantity in commerce: 809 units
Distribution: Worldwide distribution. US nationwide, Australia, Bahrain, Bulgaria, Canada, Greece, Italy, Malaysia, Mexico, Qatar, Russia, Spain, and United Kingdom.
Product codes and lots: All Lots. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1180-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1180-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-16

Product code MED

K131078Class IISystem 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation / cleared 2013-07-05

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)