The Recall Desk
SevereFDA (Devices)·Z-2265-2019·Announced 2019-08-21

Degania Silicone Recalls Jackson-Pratt Channel Drains Due to Breakage Risk

Degania Silicone is recalling 2,160 units of Cardinal Health Jackson-Pratt Channel Drains because they may break during use, potentially requiring additional surgery.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a medical device defect that requires additional surgical intervention to remove the broken part from the patient's body, which constitutes a significant injury risk and aligns with the 'Severe' criteria for significant injury reports or high-risk device failures.

Plain-English summary

Degania Silicone, Ltd. is voluntarily recalling 2,160 units of Cardinal Health Jackson-Pratt Channel Drains (15FR and 19FR round fluted) with lot codes P1851056 and P1867059. The devices were distributed nationwide. The recall is due to a defect where the drain may break at the connection point between the clear tube and the white profile part, typically during removal.

The breakage can leave a portion of the device inside the patient, which may require additional surgical intervention to remove the broken end. The recalled product is an introduction/drainage catheter intended to drain fluids from body cavities.

Healthcare providers and facilities should stop using these specific lots and contact the recalling firm for instructions on how to return or dispose of the affected units.

The recalled product

Product
Cardinal Health Jackson-Pratt Channel Drain 19FR, 3/4 flutes, with trocar Cardinal Health: PN JP-2225 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than bloo
Affected units
2,160

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Codes: P1851056 P1867059

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by Degania Silicone, Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

Same manufacturer · Degania Silicone, Ltd.

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