Split Cath III Trays, 16F x 28CM Product Usage: The Split Cath III is indicated for use in attaining long term vascular
FDA device recall Z-2592-2014 · posted 2014-09-04 · Terminated
Recall details
- Recalling firm
- Medical Components, Inc dba MedComp
- Reason for recall
- The Split Cath III Trays were incorrectly labeled as 16F x 32CM Split Cath III instead of 28CM.
- Action taken
- Medcomp sent a Recall Notification letter, dated August 4, 2014, to all affected customers. The letter identified the affected product, problem, and action to be taken. Customers were requested to respond and return all affected product. For questions call contact Susan Smith at ssmith@medcompnet.com.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- MSD
- Quantity affected
- 110
- Distribution
- USA Nationwide Distribution
- Date initiated
- 2014-08-04
- Date posted
- 2014-09-04
- Date terminated
- 2014-12-10
- Location
- Harleysville, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM (K121848) | Medical Components, Inc. | 2012-09-21 |