Recall Z-2162-2023
MEDLINE INDUSTRIES, LP - Northfield · initiated May 18, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATH PACK, Model Number DYNJ83105; b) TESIO, Model Number DYNJ83251; c) ANGIOGRAPHY PACK-LF, Model Number DYNJ83508; d) OR ANGIOGRAM PACK-LF, Model Number DYNJ83656; e) FERRELL-DUCAN ANGIO, Model Number DYNJ83696; f) ANGIO KIT PACK, Model Number DYNJ83746; g) M&E ARTERIOGRAM PK, Model Number DYNJ83815; h) ANGIOGRAPHY CV RAD PACK, Model Number DYNJ83918; i) ANGIO PACK, Model Number DYNJ83936; j) ARTERIOGRAM - SUMMIT PACK, Model Number DYNJ84040; k) ANGIO PACK, Model Number DYNJ84190; l) ANGIO, Model Number DYNJ902507C; m) ANGIO, Model Number DYNJ902507D; n) ANGIO, Model Number DYNJ905151B; o) PACK ANGIOPLASTY CV,8405, Model Number DYNJ906766B; p) (13) STC IVC FILTER/ANGIOGRAM, Model Number DYNJ908249A; q) OR ANGIOGRAM, Model Number DYNJ909267; r) RADIOLOGY PACK #108402-LF, Model Number DYNJVB1000; s) HYBRID OR PACK, Model Number SYNJ10303C
Codes / lots: all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNJ83105, UDI/DI (EA)10195327231514, UDI/DI (CS)40195327231515; b) Model Number DYNJ83251, UDI/DI (EA)10195327248659, UDI/DI (CS)40195327248650; c) Model Number DYNJ83508, UDI/DI (EA)10195327273163, UDI/DI (CS)40195327273164; d) Model Number DYNJ83656, UDI/DI (EA)10195327288228, UDI/DI (CS)40195327288229; e) Model Number DYNJ83696, UDI/DI (EA)10195327299125, UDI/DI (CS)40195327299126; f) Model Number DYNJ83746, UDI/DI (EA)10195327300692, UDI/DI (CS)40195327300693; g) Model Number DYNJ83815, UDI/DI (EA)10195327311018, UDI/DI (CS)40195327311019; h) Model Number DYNJ83918, UDI/DI (EA)10195327313807, UDI/DI (CS)40195327313808; i) Model Number DYNJ83936, UDI/DI (EA)10195327318550, UDI/DI (CS)40195327318551; j) Model Number DYNJ84040, UDI/DI (EA)10195327329709, UDI/DI (CS)40195327329700; k) Model Number DYNJ84190, UDI/DI (EA)10195327341961, UDI/DI (CS)40195327341962; l) Model Number DYNJ902507C, UDI/DI (EA)10195327137885, UDI/DI (CS)40195327137886; m) Model Number DYNJ902507D, UDI/DI (EA)10195327336561, UDI/DI (CS)40195327336562; n) Model Number DYNJ905151B, UDI/DI (EA)10195327219963…
Reason for recall
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
FDA-determined cause: Device Design
Action taken
Medline distributed their recall notices to their consignees beginning on 05/18/2023 by letter. The notices explained the problem, and the risk and requested the destruction of the products. Distributors were directed to notify their consignees, have the customers document and destroy any affected product, and include your customers quantities on the response form. Beginning on 05/23/2023, Medline issued another notice to a separate group of consignees requesting that the kits be over labeled. Distributors were directed to notify the customers and have them return any affected product to the distributor for collection and return to Medline. Questions: please contact the Recall Department at 866-359-1704
Details
- Recall number
- Z-2162-2023
- Initiated
- May 18, 2023
- Posted by FDA
- July 20, 2023
- Product code
- OES – Cardiac Catheterization Kit
- Quantity
- # included in 3,740,814 units total
- Distribution
- Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2154-2023 Class II | Medline Probe Cover Kits, Model Numbers: DYNJE5900, DYNJE5910, DYNJE5920, DYNJE5930…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | 05/18/2023Open, Classified |
| Z-2155-2023 Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | 05/18/2023Open, Classified |
| Z-2156-2023 Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a)…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | 05/18/2023Open, Classified |
| Z-2157-2023 Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | 05/18/2023Open, Classified |
| Z-2158-2023 Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a)…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | 05/18/2023Open, Classified |
| Z-2159-2023 Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a)…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | 05/18/2023Open, Classified |
| Z-2160-2023 Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a)…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | 05/18/2023Open, Classified |
| Z-2161-2023 Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a)…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | 05/18/2023Open, Classified |
| Z-2163-2023 Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a.…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | 05/18/2023Open, Classified |
| Z-2164-2023 Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a)…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | 05/18/2023Open, Classified |
| Z-2165-2023 Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a)…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | 05/18/2023Open, Classified |
| Z-2166-2023 Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a)…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | 05/18/2023Open, Classified |
| Z-2167-2023 Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a)…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | 05/18/2023Open, Classified |
| Z-2168-2023 Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a)…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | 05/18/2023Open, Classified |
| Z-2169-2023 Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a)…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | 05/18/2023Open, Classified |
| Z-2170-2023 Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a)…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | 05/18/2023Open, Classified |
| Z-2171-2023 Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | 05/18/2023Open, Classified |
| Z-2172-2023 Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a)…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | 05/18/2023Open, Classified |
| Z-2173-2023 Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a)…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | 05/18/2023Open, Classified |
| Z-2174-2023 Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | 05/18/2023Open, Classified |
| Z-2175-2023 Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a)…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | 05/18/2023Open, Classified |
| Z-2176-2023 Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a)…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | 05/18/2023Open, Classified |
| Z-2177-2023 Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a)…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | 05/18/2023Open, Classified |
| Z-2178-2023 Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | 05/18/2023Open, Classified |
| Z-2179-2023 Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a)…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | 05/18/2023Open, Classified |
| Z-2180-2023 Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a)…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | 05/18/2023Open, Classified |
| Z-2181-2023 Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a)…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | 05/18/2023Open, Classified |
| Z-2182-2023 Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a)…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | 05/18/2023Open, Classified |
| Z-2183-2023 Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a)…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | 05/18/2023Open, Classified |
| Z-2184-2023 Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a)…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | 05/18/2023Open, Classified |