Perrigo Recalls Orbit Soft Infusion Sets Due to Connector Incompatibility
Perrigo Diabetes Care is recalling Orbit soft Infusion sets because the luer-lock connectors are incompatible with standard infusion pumps.
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 involves a medical device defect that prevents proper connection to infusion pumps, creating a risk of harm through medication delivery failure, but no injuries or illnesses are reported in the source text.
Plain-English summary
Perrigo Diabetes Care is recalling specific batches of Orbit soft Infusion sets, 9 mm soft cannula, P10 (42") tubing. These sterile, single-use devices are intended for the subcutaneous delivery of medication, such as insulin, from an external infusion pump.
The recall was initiated after Perrigo was notified by its supplier, Ypsomed AG, that the affected batches were manufactured with non-conforming female luer-lock connectors. These connectors are incompatible with standard male luer-lock connectors, preventing proper connection to compatible infusion pumps. The recall covers 7,924 units distributed nationwide, including Georgia and Texas.
Consumers should stop using the affected infusion sets and contact Perrigo Diabetes Care for instructions on how to return the product. The affected product codes are 400064, 400069, 400070, and 400072, with UPC 7613117009502.
The recalled product
- Product
- Orbit soft Infusion sets, 9 mm soft cannula, P10 (42") tubing; Single-Use Set Orbit Infusion Sets are sterile, non-pyrogenic, single-use devices intended to be used for subcutaneous delivery of medication , for example insulin, from an external infusion pump.
- Manufacturer
- Perrigo Diabetes Care
- Category
- Medical Device — Infusion Sets
- Affected units
- 7,924
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 (4)
- 400064
- 400069
- 400070
- & 400072 UPC: 7613117009502
Distribution
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