Carefusion Recalls Jamshidi Needles Due to Compromised Sterile Packaging
Carefusion 2200 Inc is recalling 14,200 Jamshidi (TJ) 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 is classified as FDA Class II. The hazard involves potentially compromised sterile packaging, which is a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Carefusion 2200 Inc is recalling 14,200 units of Jamshidi (TJ) Needles BM ASP MAC. The affected products are sterile needles in various gauges and lengths, including 13G x 3.5, 8G x 4, 11G x 3.5, 8G x 6, and 11G x 6.
The recall was initiated because the integrity of the sterile packaging is potentially compromised. This defect could affect the sterility of the needles, posing a risk to patient safety if the products are used.
The affected products were distributed nationwide in the United States and internationally to Australia, Brazil, Canada, China, Japan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, and Vietnam. Specific lot numbers are listed in the structured product information. Healthcare providers and consumers should stop using these products and contact the manufacturer for further instructions.
The recalled product
- Product
- JAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d.) 8G x 6, e.) 11G x 6]; STERILE;
- Manufacturer
- Carefusion 2200 Inc
- Affected units
- 14,200
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 (20)
- Product Code: a.) TJM3513 / LOT 0000836582
- 0000838949
- 0000843968
- 0000849685
- 0000852933
- b.) TJM4008 / LOT 0000841349
- 0000841348
- 0000843961
- 0000849132
- 0000852123
- 0000853877
- c.) TJM4011 / LOT 0000836575
- 0000838950
- 0000840195
- 0000843075
- 0000843076
- 0000846708
- 0000852932
- 0000853878
- 0000854861
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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