Surgical Tracecarts Recalled Due to Defective Foley Catheter Component
DeRoyal Industries is recalling 134 GeoMed Custom Tracecarts distributed in Florida that contain a recalled Foley catheter component. Affected units carry specific lot numbers with expiration dates from February 2024 through May 2025.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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: This is an FDA Class I medical device recall. The FDA's severity rubric specifies that Class I recalls must be classified as Severe (score 4) or higher; absent reported deaths or serious injuries, this recall is classified as Severe.
Plain-English summary
DeRoyal Industries Inc is recalling 134 GeoMed Custom Tracecarts (models 53-1831 ORTHO TOTAL JOINT TRACECART and 53-1836 GENERAL SURGERY TRACECART) because they contain a Nurse Assist 16FR Silver Urine Meter Foley catheter that was subsequently recalled by the manufacturer.
The affected tracecarts were distributed in Florida. For the ortho model (GTIN 0749756598088), recalled lot numbers range from 57587017 through 59548003, with expiration dates from February 2024 through May 2025. For the general surgery model (GTIN 0749756598132), recalled lot numbers range from 58654875 through 59661866, with expiration dates from June 2024 through May 2025.
Healthcare facilities that received these tracecarts should identify affected units using the model and lot numbers provided and cease using them immediately. Facilities should contact DeRoyal Industries for instructions on replacement or return of the affected equipment. Additional details are available through FDA recall number Z-1382-2024.
The recalled product
- Product
- GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART
- Manufacturer
- DeRoyal Industries Inc
- Hazard
- Affected units
- 134
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 (20)
- a) 53-1831 ORTHO TOTAL JOINT TRACECART
- GTIN 0749756598088
- Lot Numbers: 57587017 exp 2/1/2024
- 57760377 exp 2/1/2024
- 58185167 exp 5/1/2024
- 58628933 exp 6/1/2024
- 58834059 exp 9/1/2024
- 58864266 exp 7/1/2024
- 59223364 exp 7/1/2024
- 59355050 exp 2/1/2025
- 59548003 exp 5/1/2025
- b) 53-1836 GENERAL SURGERY TRACECART
- GTIN 0749756598132
- Lot Numbers: 58654875 exp 6/1/2024
- 58736096 exp 6/1/2024
- 59146688 exp 7/1/2024
- 59223356 exp 7/1/2024
- 59443367 exp 11/1/2024
- 59510136 exp 11/1/2024
- 59515455 exp 3/1/2025
Distribution
Distributed in 1 state:
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