ASEPT 600 ml Drainage Kit — Class II medical device recall Z-0562-2015
Terminated recall by Pfm Medical Inc, reported 2014-12-17, distributed nationwide. PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial
| Recall number | Z-0562-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfm Medical Inc, Carlsbad, CA, United States |
| Recall initiated | 2014-10-20 |
| Classified | 2014-12-09 |
| Reported by FDA | 2014-12-17 |
| Terminated | 2015-04-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, MY |
| Quantity | 1,470 units |
| Reason classes | microbial contamination, sterility |
| Lot numbers | 1301-009, 1307-065 |
| Model numbers | 622287, M7052 |
Product
ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit is an accessory to be used to connect to the ASEPT Pleural or Peritoneal Drainage Catheter to drain fluid from the chest or abdomen.
Reason for recall
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0562-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.