Agency classClass IIOur severity:Low FDA (Devices)·Z-1582-2016·Announced 2016-05-04

Teleflex Pleur-evac Chest Drainage System Recalled for Missing Tyvek Bag Label

Teleflex Medical is recalling Pleur-evac Chest Drainage Systems because the Tyvek bag label is missing, preventing identification of material code, lot number, and expiration date.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is for a documentation issue (missing label) that does not directly cause adverse health consequences, fitting the 'Low' severity criteria for packaging-only problems.

Plain-English summary

Teleflex Medical is recalling 12,124 units of the Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control, REF A-6000-08LF. The recall is due to a missing label on the Tyvek bag, which is used by customers to identify the material code, lot number, and expiration date once the product is removed from the shipper box.

The affected products are sterile, single-use chest drainage systems intended for post-operative use. The recall covers worldwide distribution, including the United States and several international locations. Specific product codes and lot numbers are listed in the official recall notice.

Healthcare facilities and customers should stop using the affected products and contact Teleflex Medical for instructions on how to return or dispose of them.

The recalled product

Product: Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control, REF A-6000-08LF, Rx Only, Teleflex Medical. Product Usage: Pleur-Evacs are sterile, single-use, chest drainage systems intended for post-operative use
Manufacturer: Teleflex Medical
Category: Medical Device — Chest Drainage System
Hazard: mis-labeling
Affected units: 12,124

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Product Code A-1500-08LF - Lot/Batch Numbers: 74J1501715
74K1501006
74L1500163
Product Code A-430-08LF - Lot/Batch Numbers: 74K1500975
74K1502313
74L1500164
74L1500165
Product Code A-6000-08LF - Lot/Batch Numbers: 74K1500364
74K1500365
74K1500367
74K1500907
74K1500908
74K1501007
74K1501008
74K1501010
74K1501014
74K1502274
74L1502302
74L1502304
Product Code A-6002-08LF - Lot/Batch Numbers: 74K1500391

Distribution

Distributed nationwide across the United States.

The notice also names 36 states specifically:

Same manufacturer · Teleflex Medical

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