The Recall Desk
SevereFDA (Devices)·Z-2262-2019·Announced 2019-08-21

Degania Silicone Jackson-Pratt Channel Drain Recall for Breakage Risk

Degania Silicone is recalling 6,080 units of Cardinal Health Jackson-Pratt Channel Drains because they may break during use, 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 broken parts from a patient's body, which constitutes a significant injury risk and fits the 'Severe' criteria for significant injury reports or high-risk device failures.

Plain-English summary

Degania Silicone, Ltd. is recalling 6,080 units of Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes, with trocar (Product Number: JP-2189). The affected lots are P1841752, P1852268, and P1845823. The devices were distributed nationwide.

The recall was initiated because the 15FR and 19FR round fluted drain channel drains may break during use, specifically at the connection point between the clear tube and the white profile part. This breakage is most likely to occur during removal of the device.

If a drain breaks, it may require additional surgical intervention to remove the broken end from the patient's body. Healthcare providers and patients should be aware of this potential risk during the use and removal of these specific devices.

The recalled product

Product
Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes, with trocar Product Number: JP-2189 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 blo
Affected units
6,080

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: P1841752 P1852268 P1845823

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 →