Medline Robotic-LF Complete Delivery System Recall Due to Sterility Concerns
Medline Industries is recalling 122 units of the Robotic-LF Complete Delivery System because the sterile packs did not complete a sterilization cycle, meaning sterility cannot be guaranteed.
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 recall is classified as FDA Class II. The hazard involves a failure in the sterilization process for a medical device, which poses a significant risk of infection or serious injury if used, meeting the criteria for a Severe rating.
Plain-English summary
Medline Industries Inc is recalling 122 units of the Robotic-LF Complete Delivery System (REF CDS984543B, Lot 20AKA927, Expiration 2020-09-30). The recall was initiated because the sterile pack inside the system did not go through a complete sterilization cycle. As a result, the sterility of these components cannot be guaranteed.
The affected products were distributed only in California to three facilities: Torrance Memorial Medical, Hoag Memorial Hospital, and Owens/Minor VMI. No governmental, Canadian, or Mexican consignees were involved.
Healthcare providers and facilities should stop using the affected units and contact Medline Industries for instructions on return or disposal. Consumers are not directly affected as this is a professional medical device distributed to specific healthcare facilities.
The recalled product
- Product
- Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350
- Manufacturer
- Medline Industries Inc
- Affected units
- 122
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 (1)
- REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Medline Industries 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.
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