Z-1596-2013Class II

Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E. STERIS Corporation, Mentor, OH 44060 QLC1677E...

Name: Z-1596-2013 Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E. STERIS Corporation, Mentor, OH 44060 QLC1677E...
Creator: Steris Corporation
Published: 2013-03-04
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2013-03-04 / Terminated / root cause: labeling and UDI

FDA source

Steris Corporation began a recall of Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E. STERIS Corporation, Mentor, OH 44060 QLC1677E, QRC1699E, QPC1721E and QFC1683E contain processing... on 2013-03-04. FDA classified it as Class II and gives the reason as "During a routine label review, the firm identified four SYSTEM 1E Quick Connects that will be updated to reflect the removal of obsolete device models. This labeling review process also highlighted the opportunity to...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1596-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-04
Posted: 2013-06-26
Terminated: 2013-07-02
Recalling firm: STERIS Corporation
Product: Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E. STERIS Corporation, Mentor, OH 44060 QLC1677E, QRC1699E, QPC1721E and QFC1683E contain processing instructions, a Quick Reference Wall Chart and a flow unit. The flow unit consists of a Quick Reference Card, tubing, tethers and adapters for connecting specified devices to Flexible Processing Trays/Containers.
Product code: MED Sterilant, Medical Devices
Reason for recall: During a routine label review, the firm identified four SYSTEM 1E Quick Connects that will be updated to reflect the removal of obsolete device models. This labeling review process also highlighted the opportunity to combine two existing quick connects into a single product while eliminating the obsolete models.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: STERIS sent a Customer Notification letter dated February 19, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to replace their existing labels with labels they provided in their customer notification package. We apologize for any inconvenience this may have caused you and as always STERIS Corporation is dedicated to support our products and valued Customers. If you have any questions regarding this matter, please contact your STERIS Capital Account Manager. For further questions please call (440)392-7348
Quantity in commerce: QLC1677E: 38; QRC1699E: 128 & QPC1721E/QFC1683E: 0
Distribution: Nationwide Distribution including the states of AK, AZ, CA, CO, FL, IL, IN, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NY, OH, OK, OR, PA, SD, TN, TX, VA, WA, WI and WY.
Product codes and lots: LOT NUMBERS: QLC1677E: 1986157 - 2740157; QRC1699E: 1953884- 3376282 & QPC1721E/ QFC1683E: 3809423-Q001121.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1596-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1596-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-26

Product code MED

K113520Class IISystem 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation / cleared 2012-02-21

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)