[pending] Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Pending LLM rewrite. Source: FDA_DEVICE Z-1888-2025.
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: Pending LLM scoring against the rubric.
Plain-English summary
Potential breach of sterile barrier packaging.
The recalled product
- Product
- Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
- Manufacturer
- Mozarc Medical US LLC
- Category
- Medical Device — Devices
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)
- Model No.8888123405P
- 8888123411P
- 8888128455P
- 8888128461P
- 8888119365P
- 8888119371P
- 8888133505P
- UDI: 20884521157788
- 20884521157825
- 20884521157856
- 20884521157894
- 20884521157719
- 10884521157750
- 20884521157924
- Lot/Serial No. 2204000102
- 2228000068
- 2228000070
- 2234800148
- 2234800159
- 2234800160
Distribution
Distributed nationwide across the United States.
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