Z-1158-2014 Class II Terminated
FDA device recall Z-1158-2014 was initiated by Smith & Nephew Inc. on Jan 9, 2014 and is designated Class II. Reason for recall: Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the… The recall status is terminated (terminated Sep 26, 2014). Affected quantity: 1,710,773 invididuals units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 19, 2014
- Initiation Date
- Jan 9, 2014
- Termination Date
- Sep 26, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,710,773 invididuals units
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, KY, LA, MA, MS, MT, NC, NJ, NV, NY, OH, OR, PA, TN, TX, VA, WA, WI, WV, HI and the countries Dubai, Curacao, Argentina, Australia, Chile, Germany, France, England, Hong Kong, Kuwait, Lebanon, Libya, Sri Lanka, Malaysia, New Zealand, Manila, Saudi Arabia, South Africa, Singapore, Turkey, Taipei and Vietnam.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1158-2014
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026