Carefusion Recalls Thoracentesis and Paracentesis Kits Due to Sterility Concerns
Carefusion 2200 Inc is recalling 1,200 sterile thoracentesis and paracentesis kits because their packaging integrity may be compromised.
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: The recall involves a potential breach of sterile packaging for invasive medical devices, which presents a risk of infection. This aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Carefusion 2200 Inc is recalling 1,200 units of the Thoracentesis/Paracentesis Kit 10/CS. The recall is being conducted because the integrity of the sterile packaging for these medical devices is potentially compromised.
The affected product is identified by Product Code TPK1001 and specific lot numbers: 0000837811, 0000842215, 0000840336, and 0000851185. These kits were distributed nationwide in the United States as well as in Australia, Brazil, Canada, China, Japan, Kuwait, Malaysia, Mexico, the Netherlands, New Zealand, the Philippines, Singapore, South Africa, Taiwan, Thailand, the United Arab Emirates, and Vietnam.
Healthcare providers and facilities should check their inventory for the specific lot numbers listed above. If the affected kits are found, they should be removed from use and returned to the manufacturer or the appropriate regulatory authority as directed.
The recalled product
- Product
- Thoracentesis/ Paracentesis Kit 10/CS; STERILE;
- Manufacturer
- Carefusion 2200 Inc
- Category
- Medical Device — Surgical Kits
- Affected units
- 1,200
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 (4)
- Product Code: TPK1001 / LOT 0000837811
- 0000842215
- 0000840336
- 0000851185
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Carefusion 2200 Inc 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 6 products in this recall →Related recalls
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