CareFusion Recalls Adult and Pediatric Manual Resuscitators Due to Oxygen Flow Blockage
CareFusion is recalling 14,112 manual resuscitators because a blocked oxygen connector may prevent supplemental oxygen from reaching the patient.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states the defect 'may pose a serious patient safety risk' and involves a critical life-support function (oxygen delivery), which aligns with the rubric criteria for a Severe (4) rating involving significant injury risk or structural defects in high-risk medical devices.
Plain-English summary
CareFusion 2200 Inc is recalling 14,112 units of Adult, Pediatric, and Infant Manual Resuscitators. The affected products include various configurations with oxygen reservoir bags, tubing, and masks, identified by specific product codes and lot numbers listed in the recall notice.
The recall was initiated after CareFusion received four customer reports that an oxygen connector component within the resuscitation bag was occluded. This blockage disables the flow of supplemental oxygen to the resuscitation bag, which the company states may pose a serious patient safety risk.
The affected units were distributed nationwide in the United States, specifically in the states of AZ, CA, CO, DE, FL, GA, IL, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NM, NY, OH, PA, TX, UT, and WA. Users should check their inventory for the specific product codes and lot numbers provided in the official recall documentation and contact CareFusion for instructions on returning the devices.
The recalled product
- Product
- 1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; 2) Adult Manual Resuscitator, 2K8005, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask; 3) Adult Manual Resuscitator, 2K8017, Variable Volume Oxygen Reservoir Tubing, Adult Mask; 4) Adult Manual…
- Manufacturer
- Carefusion 2200 Inc
- Affected units
- 14,112
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)
- 1) Product Code 2K8005
- Lot Numbers: 0000355656
- 0000355659
- 0000355662
- 0000355664
- 0000355665
- 0000355666
- 0000355668
- 2) Product Code 2K8004
- Lot Number: 0000355673
- 3) Product Code 2K8017
- Lot Numbers: 0000355676
- 0000355677
- 4) Product Code 2K8034
- Lot Number: 0000355688
- 5) Product Code 2K8035
- Lot Number: 0000358023
- 6) Product Code 2K8037
- Lot Number: 0000358025
- 7) Product Code 2K8040
Distribution
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