Carefusion 2200 Recalls Jamshidi Bone Marrow Needles Due to Packaging Integrity
Carefusion 2200 Inc is recalling sterile Jamshidi bone marrow needles because the integrity of the sterile packaging is potentially 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 sterile medical device where the integrity of the sterile packaging is potentially compromised. This creates a risk of infection or harm, but the source text does not report any specific illnesses or injuries, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Carefusion 2200 Inc is recalling specific lots of sterile Jamshidi (TJ) bone marrow needles. The recall is being conducted because the integrity of the sterile packaging is potentially compromised.
The affected products include Jamshidi (TJ) bone marrow needles in various sizes: 13G x 3.5, 8G x 4, 11G x 4, 8G x 6, and 11G x 6. The recall covers specific product codes and lot numbers, including TJC3513, TJC4008, TJC4011, TJC6008, and TJC6011.
These products were distributed nationwide in the United States and in several international markets, including 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 stop using the affected lots and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- JAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.) 8G x 6, e.) 11G x 6]; STERILE;
- Manufacturer
- Carefusion 2200 Inc
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 (20)
- Product Code: a.) TJC3513 / LOT 0000848831
- 0000851431
- 0000854856
- Product Code: b.) TJC4008 / LOT 0000841227
- 0000846706
- 0000848560
- 0000849684
- 0000853455
- c.) TJC4011 / LOT 0000840667
- 0000841228
- 0000845874
- 0000849717
- 0000850937
- 0000852121
- d.) TJC6008 / LOT 0000841216
- 0000848569
- 0000851432
- 0000852122
- 0000853458
- e.) TJC6011 / LOT 0000841124
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.
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