FDA (Devices) recall action 90516

MEDLINE INDUSTRIES, LP - SPT recalled 8 products on 2022-08-03

The FDA (Devices) publishes a recall like this one as 8 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 8 pages.

Products: 8
Announced: 2022-08-03
Critical: 0
Units: 42,823

Why these products were recalled

Kits contain leaking bottles of isopropyl alcohol

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.

1–8 of 8

HighFDA (Devices)··2022-08-03
Medline Custom Surgical Kits Recalled for Leaking Isopropyl Alcohol Bottles
Medline has recalled custom neurosurgical procedure kits nationwide due to leaking bottles of isopropyl alcohol. The leakage poses a risk of contamination and chemical exposure during surgical procedures.
Product
Medline Custom procedural kits labeled as follows: a. GP-NEURO PACK, b. KIT NEUR FUS LUM POST, c. KIT PEDI VP SHUNT, d. KIT STC NEURO SPINE GENERIC, e. MAIN BASIC NEURO, f. MAJOR NEURO PK-LF, g. NEURO, h. NEURO CERVICAL PACK, i. NINOR NEURO PK-LF, j. VP SHUNT PACK Model/Catalog
Category
Distribution
0 states
HighFDA (Devices)··2022-08-03
Medline Medical Convenience Kits Recalled for Leaking Isopropyl Alcohol Bottles
Medline is recalling medical convenience kits distributed nationwide that contain leaking bottles of isopropyl alcohol. Users should stop using the affected kits.
Product
Medline Convenience kits labeled as follows: a. BEDSIDE PICC CDS, Model Number CDS984642, b. VASCULAR CDS, Model Number DYNJ902880J, c. VASCULAR CDS, Model Number DYNJ902880K, d. OPEN HEART A & B, Model Number DYNJ904831F, e. OPEN HEART MHS, Model Number DYNJ905394A, f. OPEN HEA
Category
Distribution
0 states
HighFDA (Devices)··2022-08-03
Medline skin prep kits recalled due to leaking isopropyl alcohol bottles
Medline Industries is recalling 1,880 units of skin prep convenience kits with models DYNDP1127A and DYNDP1131 distributed nationwide due to leaking bottles of isopropyl alcohol.
Product
Medline Convenience kits labeled as: a. WET SKIN PREP TRAY, b. SKIN PREP TRAY W/CHG Model/Catalog Number: Model numbers: a. DYNDP1127A, b. DYNDP1131
Category
Distribution
0 states
HighFDA (Devices)··2022-08-03
Medical Device Kits Recalled for Leaking Isopropyl Alcohol
Medline Industries is recalling medical device kits nationwide due to leaking isopropyl alcohol bottles. Approximately 28,745 units are affected. Consumers should stop using affected kits and contact the manufacturer.
Product
Z-1477-2022
Category
Distribution
0 states
HighFDA (Devices)··2022-08-03
Medline Convenience Surgical Kits Recalled Due to Leaking Isopropyl Alcohol
Medline Convenience surgical kits containing leaking bottles of isopropyl alcohol are being recalled nationwide. The leaking alcohol poses a risk of chemical exposure to healthcare workers and potential contamination of the surgical field.
Product
Medline Convenience kits labeled as: a. MAJOR VASCULAR CDS, b. POST OP KIT, c. KIT NEURO FUS LUM POST SANSUR, d. KIT NEURO FUS LUM POST SANSUR , e. PRE-OP ACCESSORY KIT CHOICE, f. DEEP BRAIN STIMULATION PACK, g. DEEP BRAIN STIMULATION PACK, h. MINIMALLY INVASIVE PACK-LF, i. EVLP
Category
Distribution
0 states
HighFDA (Devices)··2022-08-03
Medline LAP CHOLE convenience kits recalled for leaking isopropyl alcohol
Medline is recalling LAP CHOLE convenience kits due to leaking bottles of isopropyl alcohol. The affected kits were distributed nationwide.
Product
Brand Name: Medline Product Name: convenience kits labeled as: LAP CHOLE Model/Catalog Number: DYNJ907150
Category
Distribution
0 states
HighFDA (Devices)··2022-08-03
Medline Medical Kits Recalled for Leaking Isopropyl Alcohol
Medline convenience kits containing leaking bottles of isopropyl alcohol are being recalled. Approximately 477 units were distributed nationwide and should not be used.
Product
Medline convenience kits labeled as: a. MIDDLE EAR PACK-LF, Model DYNJ0689093V, b. EENT PACK, Model Number DYNJ62927 Model/Catalog Number: a. DYNJ0689093V, b. DYNJ62927
Category
Distribution
0 states
HighFDA (Devices)··2022-08-03
Medline medical device kits recalled for leaking isopropyl alcohol bottles
Medline Industries is recalling medical convenience kits containing leaking bottles of isopropyl alcohol due to chemical exposure risk. The recall affects 288 units distributed nationwide.
Product
Medline convenience kits: a. VENOUS ACCESS PACK-LF, Model Number DYNJ36725B, Lot codes: 19UBB149, b. KIT LB SHUNT, Model NumberDYNJ905860A, Lot codes: 22OBG246, 21LBU048, 21GBI196, 21KBK242, 21EBH567 Model/Catalog Number: a. Model Number DYNJ36725B, b. Model Number DYNJ905860
Category
Distribution
0 states