FDA Medical Device Recalls (openFDA)
Degania Silicone, Ltd.: Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body fluids for surgical use.
- Recall number
- Z-0899-2018
- Recalling firm
- Degania Silicone, Ltd.
- Product
- Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body fluids for surgical use.
- Status
- Terminated
- Initiated
- 2017-10-03
- Posted
- 2018-02-20
- Terminated
- 2020-10-21
- Reason
- Sterile pouches are missing labels on them. The boxes themselves are properly labeled. The issue is related to the production lot P1607442 only.
- Root cause
- Error in labeling
- Action
- An Urgent Medical Device Correction letter, dated October 03, 2017, was sent to the customer. The letter identified the affected device and the reason for the recall. The letter instructed the consignee to check its stock in order to remove all mislabeled product from the market and eliminate potential risk of misuse. The customer was instructed to return the completed Confirmation Sheet to Degania Silicone, as well as any unlabeled product. Questions regarding the recall should be directed to Katia Kayam, Customer Complaints Officer at Katia@ds-il.com.
- Quantity
- 4,000 units
- Distribution
- US Distribution to Puerto Rico.
- Lot, serial or model codes
- Lot No P1607442.
- 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