Z-2766-2020Class II
Endoscopic Cleaning Brush -
MEDLINE INDUSTRIES, LP - Northfield / initiated 2020-07-09 / Terminated
Medline Industries Inc began a recall of Endoscopic Cleaning Brush - Product Usage: Endoscopic cleaning brushes are single use devices intended to clean the interior of endoscopes after endoscopy... on . FDA classified it as Class II and gives the reason as "Potential risk of brush detachment during cleaning". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-2766-2020
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Endoscopic Cleaning Brush - Product Usage: Endoscopic cleaning brushes are single use devices intended to clean the interior of endoscopes after endoscopy procedures. The brush is threaded through the biopsy valve and pulled through the interior of the endoscope to remove debris.
- Product code
- MNL Accessories, Cleaning Brushes, For Endoscope
- Reason for recall
- Potential risk of brush detachment during cleaning.
- FDA root cause
- Under Investigation by firm
- Action
- On July 9th 2020, the firm sent a letter to their customer with the following instructions: REQUIRED ACTION: 1. Immediately check your stock for item number DYK1002DBDE & DYK1002DCB. The four affected lot numbers are GM10, GJ25, HA05, and HA20. Quarantine and destroy all affected product. 2. Please return the completed enclosed destruction form listing the quantity of affected product(s) destroyed. Even if you do not have any affected product please complete and return the form, as indicated on the destruction form. Your account will receive credit when the destruction form is returned. 3. If you have transferred possession of this product to another individual, to another department or another location in your organization you are required by FDA regulations to notify them of this recall communication.
- Quantity in commerce
- 1,400 total units
- Distribution
- US Nationwide distribution including in the states of CA, IN and OH.
- Product codes and lots
- Model# : DYK1002DCB and DYK1002DBDE LOT #: GM10, GJ25, HA05, and HA20
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2766-2020 | Class II | Terminated | Voluntary: Firm initiated |
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