FDA Medical Device Recalls (openFDA)
Molded Products Inc: Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. Intended for use with medically prescribed hemodialysis blood tubing.
- Recall number
- Z-0969-2013
- Recalling firm
- Molded Products Inc
- Product
- Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. Intended for use with medically prescribed hemodialysis blood tubing.
- Status
- Terminated
- Initiated
- 2012-06-19
- Posted
- 2013-03-18
- Terminated
- 2013-08-14
- Reason
- The recalled product leaks at the connection site.
- Root cause
- Process control
- Action
- The firm's one customer was notified of the recall by phone call on 5/8/2012. The customer returned the affected product once the replacement product was received.
- Quantity
- 1200 sets
- Distribution
- Distributed to one customer in Michigan.
- Lot, serial or model codes
- Lot numbers: 80106 and 80106b
- 510(k) numbers
- ["K003712"]
- PMA numbers
- not on file
- Product code
- KOC
- Firm FEI
- 1000138417
- Firm city
- Harlan
- Firm state
- IA
- 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