Severity
Moderate
FDA Devices recall · Reported March 1, 2017
Product sterility compromised due to breach of sterile barrier
Degania Silicone, Ltd. recalled Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Sterile. Rx Di… - a moderate-severity action.
Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Sterile. Rx Di… was recalled by Degania Silicone, Ltd. in March 1, 2017. Reason: Product sterility compromised due to breach of sterile barrier. Check the official notice for the remedy. Verify recall #Z-1233-2017 with the FDA Devices before acting.
The recall
Degania Silicone, Ltd. issued this moderate-severity FDA Devices recall-Product sterility compromised due to breach of sterile barrier.
Sourced from official FDA Devices enforcement records. Verify recall #Z-1233-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1233-2017) was formally reported on March 1, 2017, with the manufacturer initiating the action on January 31, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Degania Silicone, Ltd. is listed as the recalling firm, operating out of Dganya Bet, N/A. Federal records list the affected scope as 3040 units.
The documented reason for this recall is: Product sterility compromised due to breach of sterile barrier Distribution data in the federal record shows the product reached: To PR only. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
3040 units
Related Recalls
6
3 from same agency
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.
Product sterility compromised due to breach of sterile barrier
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1233-2017 |
| Date reported | March 1, 2017 |
| Date initiated | January 31, 2017 |
| Recalling firm | Degania Silicone, Ltd. |
| Firm location | Dganya Bet, N/A |
| Affected scope | 3040 units |
| Distribution | To PR only |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 1, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.