Prodimed Combicath Paediatric Catheters Recalled Due to Sterility Assurance Issues
Prodimed Plastimed Division is recalling 180 units of Combicath Paediatric catheters nationwide because the company cannot assure the sterility of the devices.
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, and the hazard involves a lack of sterility assurance for an invasive medical device, which poses a significant risk of infection or serious injury.
Plain-English summary
Prodimed Plastimed Division is recalling 180 units of Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling. The specific product code is 58 223 19US, and the devices are 35 cm x 1.9 mm in size. The recall covers all lots within their expiry dates.
The recall was initiated due to a lack of assurance of sterility. This means the manufacturer cannot guarantee that the devices are sterile, which is a critical requirement for medical devices used in invasive procedures.
The affected devices were distributed nationwide. Healthcare providers and facilities that have received these specific catheters should stop using them and contact the recalling firm for further instructions on how to handle the returned units.
The recalled product
- Product
- Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling- COMBICATH 35 cm x 1.9 mm Product Code: 58 223 19US
- Manufacturer
- Prodimed Plastimed Division
- Affected units
- 180
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)
- All lots within expiry
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Prodimed Plastimed Division 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.
See all 6 products in this recall →Related recalls
Same manufacturer · Prodimed Plastimed Division
See all →- HighProdimed Combicath Paediatric Catheters Recalled for Sterility Assurance Issues
FDA (Devices) · 2020-07-15
- HighProdimed Combicath Catheters Recalled for Sterility Assurance Concerns
FDA (Devices) · 2020-07-15
- HighProdimed Combicath Catheters Recalled Due to Sterility Assurance Concerns
FDA (Devices) · 2020-07-15
- HighProdimed Combicath catheters recalled due to sterility assurance concerns
FDA (Devices) · 2020-07-15
- SevereProdimed Combicath Catheters Recalled for Sterility Assurance Concerns
FDA (Devices) · 2020-07-15
Same hazard · sterility
See all →- HighFDA recalls injectable compounded mixture in single-use syringes
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- SevereCustomed Recalls Umbilical Vessel Catheter Kits Due to Packaging Integrity Concerns
FDA (Devices) · 2014-09-10
- SevereCustomed Recalls Foley Catheter Kits Due to Packaging Integrity Concerns
FDA (Devices) · 2014-09-10
- HighPalindrome SI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure
FDA (Devices) · 2015-07-08
- HighCovidien Recalls Palindrome Precision SI Chronic Catheter Kits
FDA (Devices) · 2015-07-08
- HighFDA Recalls Palindrome Precision SI Chronic Catheter Kits for Antimicrobial Failure
FDA (Devices) · 2015-07-08
- SevereCustomed Suction Catheter Kits Recalled for Compromised Sterility
FDA (Devices) · 2014-12-10