Medline medical procedure kits, labeled as follows: a) PARACERVICAL PUD TRAY, REF DYNDH1832; b) AHS PARACERVICAL/PUDENDA
FDA device recall Z-1918-2024 · posted 2024-05-29 · Open, Classified
Recall details
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Reason for recall
- Trumpet Needle Guide ring can detach when excessive pressure is applied.
- Action taken
- Medline issued a correction notice to its consignees on 03/01/2024 via email and USPS first class mail. The notice explained the issue and requested the consignee identify and quarantine all affected products, and respond to the notice. Once the response was received Medline would provide labels to place over the affected product in stock. If the product was further distributed the party which distributed the product was directed to notify their customers.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- OJH
- Quantity affected
- 12994 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2024-03-01
- Date posted
- 2024-05-29
- Location
- Northfield, IL
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