(1) Centurion Sterile CirClamp, Reorder #200CR; (2) Centurion CirClamp with 1.1cm Bell and Insert, Reorder #210CR, Steri
FDA device recall Z-0133-2025 · posted 2024-10-18 · Open, Classified
Recall details
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Reason for recall
- Product has been identified as having holes in the packaging.
- Action taken
- The recalling firm issued letters on and dated 9/3/2024 via first class mail or email. The letter explained the reason for recall and the required action, which included: (1) Immediately check your stock for the affected item and lot numbers which can be located within the recall portal and quarantine all affected product immediately; (2) Use the link and information in the letter to complete the response form to list the quantity of affected product in inventory; (3) Upon receipt of the response form, return labels will be provided; (4) If you are a distributor or have resold or transferred the product to another company or individual, the distributor is to notify them of this recall communication. The firm included a spreadsheet with the communication that listed the items and lot numbers.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- HFX
- Quantity affected
- 498,354 kits
- Distribution
- Worldwide distribution - US Nationwide and the countries of India and Panama.
- Date initiated
- 2024-09-03
- Date posted
- 2024-10-18
- Location
- Northfield, IL
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CENTURION CIRCLAMP (K890897) | Tri-State Hospital Supply Corp. | 1989-03-28 |