FDA Medical Device Recalls (openFDA)
Degania Silicone, Ltd.: Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Sterile. Rx Distributed by Cardinal Health, USA Catalog Number: JP-2187 For wound drainage.
- Recall number
- Z-1233-2017
- Recalling firm
- Degania Silicone, Ltd.
- Product
- Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Sterile. Rx Distributed by Cardinal Health, USA Catalog Number: JP-2187 For wound drainage.
- Status
- Terminated
- Initiated
- 2017-01-31
- Posted
- 2017-02-22
- Terminated
- 2017-04-04
- Reason
- Product sterility compromised due to breach of sterile barrier
- Root cause
- Packaging process control
- Action
- Degania Silicone Ltd. issued an Urgent Recall letter dated 1/31/17 and requested return of the product to Degania Silicone 14 Thurber Boulevard, Suite A, Smithfield, RI 02917, USA.. For questions regarding this recall call +1-401-349-5373.
- Quantity
- 3040 units
- Distribution
- To PR only
- Lot, serial or model codes
- Lot Number: P1546816 Expiration date: January 2021
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GBX
- Firm FEI
- 7682
- Firm city
- not on file
- Firm state
- not on file
- 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