FDA Medical Device Recalls (openFDA)
Wolf Medical Supply Inc.: Wolf Medical Supply, Inc., WOLF-PAK REDI-FLO ELASTOMERIC INFUSION PUMP, FILL VOLUME 100 mL, FLOW RATE 2mL/Hr. Model # CT-0020-100 Item # RFC100020. Manufactured by Medpro International (Thailand) Ltd.
- Recall number
- Z-0268-2012
- Recalling firm
- Wolf Medical Supply Inc.
- Product
- Wolf Medical Supply, Inc., WOLF-PAK REDI-FLO ELASTOMERIC INFUSION PUMP, FILL VOLUME 100 mL, FLOW RATE 2mL/Hr. Model # CT-0020-100 Item # RFC100020. Manufactured by Medpro International (Thailand) Ltd.
- Status
- Terminated
- Initiated
- 2011-10-20
- Posted
- 2011-11-23
- Terminated
- 2012-04-25
- Reason
- Redi-Flo Elastomeric Infusion Pumps may have a higher flow rate than specified (more than +15%).
- Root cause
- Process control
- Action
- On 10/20/2011 Wolf Medical Supply Inc., customers were notified by telephone and email. Product was distributed to end users.
- Quantity
- 8 cases (192 units)
- Distribution
- Nationwide distribution, including Puerto Rico.
- Lot, serial or model codes
- Lot 81218 Exp 12/2011, Lot 90227 Exp 01/2012.
- 510(k) numbers
- ["K081905"]
- PMA numbers
- not on file
- Product code
- MEB
- Firm FEI
- 3007328521
- Firm city
- Fort Lauderdale
- Firm state
- FL
- 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