Medline retinal packs recalled because catheter needle may fail to retract
Medline RETINAL PACK-LF convenience kits are being recalled because the BD Insyte Autoguard catheter needle inside may be slow to retract or fail to retract during insertion. 80 units affected.
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: Risk-of-harm product: a safety needle that may not retract as designed during insertion, with no injury reported in the source.
Plain-English summary
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters, 22 GA x 1.00 IN, labelled RETINAL PACK-LF, REF DYNJ0151148B, are being recalled. The action covers 80 units.
According to Medline Industries, LP, it was identified that during insertion of the catheter, the needle is slow to retract or fails to retract. The FDA classified the action as Class II.
The affected kits carry UDI/DI 10889942050819 for each unit and 40889942050810 for the case. Distribution was nationwide in the United States, in Indiana, Kentucky, California, Michigan, Texas and Washington. The kits are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the REF and UDI codes above, quarantine it, and follow the instructions issued by Medline.
The recalled product
- Product
- Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: RETINAL PACK-LF, REF DYNJ0151148B
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — IV catheter kit
- Affected units
- 80
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 (3)
- 1) REF DYNJ0151148B: UDI/DI 10889942050819 (each)
- 40889942050810 (case)
- Lot Number 24LDA980
Distribution
Part of a larger recall action
This product is one of 3 recalled by MEDLINE INDUSTRIES, LP - Northfield 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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