Replacement floor locking cylinders for the Schaerer model 7300 surgical tables. Replacement cylinders are...
Schaerer Medical USA Inc began a recall of Replacement floor locking cylinders for the Schaerer model 7300 surgical tables. Replacement cylinders are part number 85118. Product Usage: The cylinders are... on . FDA classified it as Class II and gives the reason as "The floor locking cylinders are contained in the base of the Schaerer 7300 model surgical tables. The cylinders were manufactured with the incorrect "O" ring which may cause the cylinder to leak". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0372-2017
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Ohio Medical Instrument Co., Inc.
- Product
- Replacement floor locking cylinders for the Schaerer model 7300 surgical tables. Replacement cylinders are part number 85118. Product Usage: The cylinders are used to lock the surgical table in place.
- Product code
- JEB Table, Surgical With Orthopedic Accessories, Manual
- Reason for recall
- The floor locking cylinders are contained in the base of the Schaerer 7300 model surgical tables. The cylinders were manufactured with the incorrect "O" ring which may cause the cylinder to leak.
- Root cause tag
- manufacturing process
- FDA root cause
- Nonconforming Material/Component
- Action
- Schaerer Medical sent a Field action letters dated September 27, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. The customer is required to complete and return a response form with the number of affected tables and cylinders. All affected cylinders will be replaced in the field and returned to the manufacturer. For questions Quality Assurance at 513-272 -9116.
- Quantity in commerce
- 10 replacement cylinders.
- Distribution
- Worldwide Distribution - US Nationwide in the states of: CA, CT, FL, IA, IN, MI, MN, MO, OH, PA, and VA Replcement cylinders wre distributed
- Product codes and lots
- Lot code of the replacement cylinders, 2016-02-01
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0371-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0372-2017 | Class II | Terminated | Voluntary: Firm initiated |
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