Smiths Medical Recalls ProtectIV Plus Safety IV Catheters
Smiths Medical is recalling certain lots of ProtectIV Plus Safety IV Catheters because the safety mechanism guard may be damaged.
What this means for you
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, and the hazard involves a potential mechanical defect in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Smiths Medical ASD Inc. is recalling 219,150 units of the Model 306701 ProtectIV Plus Safety IV Catheter. The recall affects specific lots identified by the following numbers: 3635765, 3639446, 3642834, 3646828, 3646829, 3646830, 3646831, 3646832, 3646833, and 3651082.
The recall was initiated because certain lots of these catheters may exhibit damage on the safety mechanism guard. The devices are sterile and packaged in a pouch and then into an inner carton.
The affected devices were distributed in the United States to Alaska, Arizona, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Maryland, Minnesota, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, and Washington. One foreign consignee in Costa Rica also received the product. The source text does not specify instructions for consumers or healthcare providers regarding the disposition of these devices.
The recalled product
- Product
- ProtectIV¿ Plus Safety IV Catheter, sterile. Packaged in a pouch and than into an inner carton.
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device — IV Catheter
- Hazard
- Affected units
- 219,150
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 (11)
- Model number 306701
- Lot numbers: 3635765
- 3639446
- 3642834
- 3646828
- 3646829
- 3646830
- 3646831
- 3646832
- 3646833
- 3651082.
Distribution
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