CLASS II Device recall · Reported 3 Jul 2013 · FDA Enforcement Report
Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E recalled
Steris is recalling Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E, distributed nationwide in the US. The recall was initiated on 4 Mar 2013 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-1596-2013
- FDA event ID
- 65138
- Recalling firm
- Steris, Mentor, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Mar 2013
- FDA classified
- 26 Jun 2013
- Reported
- 3 Jul 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 4 Mar 2013 | Recall initiated by company | |
| 26 Jun 2013 | Classified by FDA | +114 days |
| 3 Jul 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide AlaskaArizonaCaliforniaColoradoFloridaIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMaineMichiganMissouriMississippiNorth CarolinaNebraskaNew HampshireNew YorkOhio
Stores named: Kroger
Questions about this recall
Is Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E recalled?
Yes. Steris recalled Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E on 4 Mar 2013. The recall is Class II and its status is Terminated. Recall number Z-1596-2013.
Why was it 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.
Which lots are affected?
LOT NUMBERS: QLC1677E: 1986157 - 2740157; QRC1699E: 1953884- 3376282 & QPC1721E/ QFC1683E: 3809423-Q001121.
Where was it sold?
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.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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