Chest drainage units recalled to limit their use to adults
Cardinal Health is updating the instructions for use on 1,169,726 chest drainage units to clarify that the intended patient population is adults 18 years and older.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states use on infants may confound assessment of device functionality and lead to inadequate treatment or delay, and no injuries are reported.
Plain-English summary
Cardinal Health chest drainage units and accessories are being recalled by Cardinal Health 200, LLC. The record lists the affected products by product code, including the Sentinel Seal CDU, Sentinel Seal CDU Dual Drain, Sentinel Seal CDU with Easy Change Connector, Altitude CDU Dry Suction with Easy Change Connector, Aqua-Seal CDU Wet Suction and its variants, and Thora-Seal Basic CDU, among the codes set out in the enforcement record.
The record states the firm is updating the instructions for use to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. It states that when used on infants, the CDU may not demonstrate tidaling or bubbling, which may confound the clinician's assessment of device functionality and lead to inadequate or inappropriate treatment or therapy, delay to treatment or therapy, and prolonged hospitalization.
The record lists 1,169,726 units and states all units are affected by the IFU update, with UDI-DI codes recorded in the enforcement record. Distribution was worldwide, covering the United States nationwide and Brazil, Canada, Chile, Colombia, the Dominican Republic and Mexico. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Facilities should follow Cardinal Health's instructions and the updated instructions for use.
The recalled product
- Product
- Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 8888571513 Cardinal Health Sentinel Seal CDU, Dual Drain 3. 8888571489 Cardinal Health Sentinel Seal CDU, with Easy Change Connector 4. 8888571370 Cardinal…
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Chest drainage
- Affected units
- 1,169,726
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 (6)
- Dry Suction
- Wet Suction
- One Chamber
- Two Chamber System
- Three Chamber System
- 2500 mL 50192253002667 (CS) 10192253002669 (EA)
Distribution
Distributed nationwide across the United States.
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