FDA Medical Device Recalls (openFDA)
STERILMED, INC.: Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (PLC), 34", Model (Reprocessor) Number: ZIM60-7075-106, Reprocessed by Sterilmed. Products are individually packaged in a Tyvek/poly pouch. There are 5 pouches placed inside a casepack box. Each sales unit (casepack) contains 5 devices.
- Recall number
- Z-2819-2015
- Recalling firm
- STERILMED, INC.
- Product
- Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (PLC), 34", Model (Reprocessor) Number: ZIM60-7075-106, Reprocessed by Sterilmed. Products are individually packaged in a Tyvek/poly pouch. There are 5 pouches placed inside a casepack box. Each sales unit (casepack) contains 5 devices.
- Status
- Terminated
- Initiated
- 2015-08-24
- Posted
- 2015-09-28
- Terminated
- 2016-03-11
- Reason
- Sterilmed, Inc. is recalling its reprocessed Zimmer Tourniquet Cuff, Part #ZIM60-7075-106, lot number 1846885 due to mislabeling. The affected reprocessed product is labeled as single hose devices but the devices inside the packaging are dual hose devices.
- Root cause
- Labeling False and Misleading
- Action
- Sterilmed sent an "Urgent Medical Device Recall" letter dated August 24 2015. The letter was addressed to Materials Manger, Risk Manger and Operating Room Supervisor. The letter identified the affected product, problem and actions to be taken. Customers are requested to return all affected product, sign and return the enclosed Customer Response Questionnaire and the Customer Response Form per the instructions on the Forms. For questions contact Sterilmed's Customer Care Team at 888-541-0078.
- Quantity
- 43
- Distribution
- US Nationwide Distribution in the states of CA, KY, MI, OH, UT and WI.
- Lot, serial or model codes
- Lot 1846885
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KCY
- Firm FEI
- 3001237663
- Firm city
- Maple Grove
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28