RecallRadar

FDA Device recall Z-0566-2015

Thoracentesis & Paracentesis Procedure Tray, Ref No. M7553, 850004 Product Usage: Short term percutaneous fluid drainage

On 2014-12-17 the FDA classified a Class II recall of Thoracentesis & Paracentesis Procedure Tray, Ref No. M7553, 850004 Product Usage: Short term percutaneous fluid drainage by Pfm Medical, citing PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0566-2015
ClassificationClass II
Statusterminated
Initiated2014-10-20
Published2014-12-17
Last updated2026-09-13 11:53 UTC
CompanyPfm Medical
DistributionUS

Product

Thoracentesis & Paracentesis Procedure Tray, Ref No. M7553, 850004 Product Usage: Short term percutaneous fluid drainage.

Reason

PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.

Identifiers

code_infoLot No. 1212-001, 1212-034

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0566-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.