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Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E.… recallZ-1596-2013 · Steris Corporation · initiated Mar 4, 2013

Class II Terminated All recalls posted in June 2013

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Steris Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Labeling Change Control

What the company is doing

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

Recall details

Recall number
Z-1596-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Mar 4, 2013
Posted by the FDA
Jun 26, 2013
Recalling firm
Steris Corporation
Quantity
QLC1677E: 38; QRC1699E: 128 & QPC1721E/QFC1683E: 0
Product code
MED
FDA submissions
K113520
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 description

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.

Code information (models, lots, serial numbers)

LOT NUMBERS: QLC1677E: 1986157 - 2740157; QRC1699E: 1953884- 3376282 & QPC1721E/ QFC1683E: 3809423-Q001121.

Other devices under the same FDA submission

4 devices cleared under K113520 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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