FDA (Devices) recall action 94239

MEDLINE INDUSTRIES, LP - Northfield recalled 9 products on 2024-07-10

The FDA (Devices) publishes a recall like this one as 9 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 9 pages.

Products: 9
Announced: 2024-07-10
Critical: 0
Units: 93,632

Why these products were recalled

Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–9 of 9

HighFDA (Devices)··2024-07-10
Medline Birthing Room Pack surgical kits recalled due to weak sterile seals
Medline is recalling approximately 12,588 sterile surgical kits used for childbirth procedures because weak seals on Pure Pouch components may fail and compromise sterility.
Product
Sterile convenience kit: Medline Birthing Room Pack, Pack #DYNJ38429D, containing a Pure Pouch component Sterile Sharp/Blunt Scissors 5.5", Reorder #65945 and containing a Pure Pouch component Sterile 5.5" Episiotomy Scissors, Reorder #67645.
Category
Distribution
23 states
HighFDA (Devices)··2024-07-10
Medline Neuro IR Surgical Kit Recalled Due to Weak Seals
Medline is recalling Neuro IR surgical convenience kits due to weak seals in the Pure Pouch component that may compromise sterility. The recall affects 12,588 kits distributed nationwide.
Product
Sterile surgical convenience kit: Medline Neuro IR Pack, Pack #DYNJ56073C, containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile.
Category
Distribution
23 states
HighFDA (Devices)··2024-07-10
Surgical Convenience Kits Recalled for Weak Seals Affecting Sterility
Medline Industries recalls 7,673 surgical convenience kits due to weak Pure Pouch seals that may compromise sterility. Kits were distributed nationwide to healthcare facilities.
Product
Nonsterile convenience kits: a. Medline Delivery, Pack #DYNJ901130I, containing a Pure Pouch with component Reorder #DYND04000, O.R. Scissors, S/B, 5.5 Sterile. b. Medline C-Section, Pack DYNJ902938J, containing a Pure Pouch with component Reorder #DYND04000, O.R. Scissor
Category
Distribution
23 states
HighFDA (Devices)··2024-07-10
Medline Surgical Kits Recalled for Weak Seals Compromising Sterility
Medline is recalling 12,588 sterile surgical kits with Pure Pouch components that have weak seals, potentially compromising sterility and exposing patients and surgical teams to non-sterile instruments.
Product
Sterile convenience kits: a. Medline Retrograde PK-22025203-LF, Pack #DYNJ47873K, containing a Pure Pouch containing component Sterile Curved Kelly Hemostat, Reorder #66175. b. Medline Cath Lab Pack, Pack #DYNJ56141A, containing a Pure Pouch containing component Medline D
Category
Distribution
23 states
HighFDA (Devices)··2024-07-10
Medline surgical convenience kits recalled for weak seal integrity
Medline surgical convenience kits containing Pure Pouch components with weak seals may fail to maintain sterility, potentially compromising the safety of contained medical instruments. Affected kits were distributed nationwide across 23 states.
Product
Non-sterile convenience kits: a. Medline Difficult Airway Tray W/O Cook, Pack #ACC010578, containing a Pure Pouch with component Reorder #DYNJ040408, Kelly Forceps/STD STR Sterile. b. Medline Adult/Child Intubation Kit, Pack #ACC010616 and Pack #ACC010616H, containing a P
Category
Distribution
23 states
HighFDA (Devices)··2024-07-10
Medline Surgical Convenience Kits Recalled for Weak Seal Compromise
Medline recalled 7,673 surgical convenience kits nationwide due to weak seals in the Pure Pouch component that may compromise sterility of surgical instruments. No injuries have been reported.
Product
Non-sterile convenience kits: a. Medline CC Drawer 4 IV Circulation, Pack #ACC010254B, containing a Pure Pouch component DYND04000, O.R. Scissors S/B, 5.5 Sterile. b. Medline Code Cart Drawer 2 Adult Kit, Pack ACC010365A, containing a Pure Pouch component DYNJ04048, Kelly
Category
Distribution
23 states
HighFDA (Devices)··2024-07-10
Medline surgical convenience kits recalled due to weak Pure Pouch seals
Medline is recalling over 7,600 Open Heart surgical convenience kits nationwide due to weak seals on the Pure Pouch component. The seals may fail and compromise the sterility of the surgical instruments inside.
Product
Non-sterile convenience kits: Medline Open Heart CDS, Pack #CDS981759C, containing a Pure Pouch with component Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile.
Category
Distribution
23 states
HighFDA (Devices)··2024-07-10
Medline surgical convenience kits recalled for weak seal defects
Medline Industries is recalling 12,588 sterile surgical convenience kits due to weak seals on Pure Pouch components that may breach sterility. Products were distributed nationwide across 23 states.
Product
Sterile surgical convenience kits: a. Medline Cath Lab Special Procedure, Pack #00-RDF0360, containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile. b. Medline Angiography Pack, Pack #DYNJ26488W, containing a Pure Pouch with compo
Category
Distribution
23 states
HighFDA (Devices)··2024-07-10
Sterile surgical kits recalled due to weak pouch seals risking contamination
Medline sterile surgical kits are being recalled nationwide due to weak seals in the Pure Pouch component that may allow sterility breach. The recall affects 12,588 units distributed across 23 states.
Product
Sterile surgical convenience kit: Medline Retrograde PK-22025203-LF, Pack #DYNJ47873L, containing a Pure Pouch with component Sterile Curved Kelly Hemostat, Reorder #66175.
Category
Distribution
23 states