Device recall: Surgical convenience kits labeled as: MEDLINE PAIN TRAY, Reorder Number DYNJRA1122A
Class II FDA enforcement event 91483. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
Class II, in the words of FDA
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
MEDLINE INDUSTRIES, LP - Northfield started this device recall on 7 Dec 2022. The firm address in the FDA record is in Northfield, IL. FDA put the recall in Class II. FDA event 91483 has 20 product records. The first FDA enforcement report date is 22 Feb 2023. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
20 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1109-2023 | Surgical convenience kits labeled as: MEDLINE PAIN TRAY, Reorder Number DYNJRA1122A | 120 units | Class II | Ongoing | 22 Feb 2023 |
| Z-1110-2023 | Surgical convenience kits labeled as: MEDLINE ANGIO PORT KIT W/HIGH GRADE IN, Reorder Number DYNDC2691 | 30 units | Class II | Ongoing | 22 Feb 2023 |
| Z-1111-2023 | Surgical convenience kits labeled as: MEDLINE PERF. ASSOC. CUT DOWN TRAY, Reorder Number BM17BAD | units | Class II | Ongoing | 22 Feb 2023 |
| Z-1112-2023 | Surgical convenience kits labeled as: MEDLINE CABG PACK, Reorder Number DYNDA2827 | 80 units | Class II | Ongoing | 22 Feb 2023 |
| Z-1113-2023 | Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS NEONATAL PICC TRAY, Reorder Number CVI4685 | 60 units | Class II | Ongoing | 22 Feb 2023 |
| Z-1114-2023 | Surgical convenience kits labeled as: MEDLINE BREAST BIOPSY KIT, Reorder Number DYNDA1224B | 60 units | Class II | Ongoing | 22 Feb 2023 |
| Z-1115-2023 | Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS TRACHEOSTOMY TRAY, Reorder Number TC7470 | 120 units | Class II | Ongoing | 22 Feb 2023 |
| Z-1116-2023 | Surgical convenience kits labeled as: MEDLINE PLASTICS/PEDS KIT, Reorder Number DYNDA2489 | 480 units | Class II | Ongoing | 22 Feb 2023 |
| Z-1117-2023 | Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS L & D TRAY, Reorder Number MNS9065 | 138 units | Class II | Ongoing | 22 Feb 2023 |
| Z-1118-2023 | Surgical convenience kits labeled as: a) MEDLINE GENERAL UTILITY, Reorder Number DYNDA2524 b) CENTURION MEDICAL PRODUCTS DIALYSIS ON/OFF BUNDLE, Reorder Number DT22705A c) CENTURION MEDICAL PRODUCTS ULTRASOUND PIV BUNDLE, Reorder Number IV8635D d) CENTURION MEDICAL PRODUCTS CUTDOWN TRAY, Reorder Number MNS12595 | 630 units | Class II | Ongoing | 22 Feb 2023 |
| Z-1119-2023 | Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CHEST TUBE INSERTION TRAY, Reorder Number CVI2105; b) CENTURION MEDICAL PRODUCTS VASECTOMY KIT, Reorder Number MNS11975; c) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder Number SUT11670; d) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder… | 2753 units | Class II | Ongoing | 22 Feb 2023 |
| Z-1120-2023 | Surgical convenience kits labeled as: a) MEDLINE PERF. ASSOC. CUT DOWN TRAY, Reorder Number BM17BAD; b) MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number DYNJCD0063 | 981 units | Class II | Ongoing | 22 Feb 2023 |
| Z-1121-2023 | Surgical convenience kits labeled as: MEDLINE LCPH LAB DRAW KIT, Reorder Number DYNDH1641A | 1537 units | Class II | Ongoing | 22 Feb 2023 |
| Z-1122-2023 | Surgical convenience kits labeled as: MEDLINE SHOULDER SUSPENSION I-LF, Reorder Number DYNJSHOULDER | 1280 units | Class II | Ongoing | 22 Feb 2023 |
| Z-1123-2023 | Surgical convenience kits labeled as: MEDLINE PREP TRAY, Reorder Number DYNDL1643A | 1376 units | Class II | Ongoing | 22 Feb 2023 |
| Z-1124-2023 | Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CENTRAL LINE DRESSING CHANGE K, Reorder Number DT21400; b) CENTURION MEDICAL PRODUCTS CUSTOM PORT ACCESS KIT, Reorder Number DT22255; c) MEDLINE CVC DRESSING CHANGE KIT, Reorder Number DYNDC1022GB, | 1588 units | Class II | Ongoing | 22 Feb 2023 |
| Z-1125-2023 | Surgical convenience kits labeled as: MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number DYNJCD0063 | 0 units | Class II | Ongoing | 22 Feb 2023 |
| Z-1126-2023 | Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS IR INSTRUMENT TRAY, Reorder Number SUT10675 | 192 units | Class II | Ongoing | 22 Feb 2023 |
| Z-1127-2023 | Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS CIRCUMCISION TRAY, Reorder Number CIT3345 | 144 units | Class II | Ongoing | 22 Feb 2023 |
| Z-1128-2023 | Surgical convenience kits labeled as: a) MEDLINE HAND PACK, Reorder Number DYNJ67850; b) MEDLINE SHOULDER SUSPENSION II-LF, Reorder Number DYNJSHOULDER2; c) MEDLINE TRAY BONE MARRO ASC LTX SAFE, Reorder Number P429589A; d) MEDLINE LUMBAR TRAY, Reorder Number SPEC0177; e) CENTURION MEDICAL PRODUCTS LUMBAR PUNCTURE… | 4779 units | Class II | Ongoing | 22 Feb 2023 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2022
- 839
- Share of these events in Class II
- 88%
- Product records in this event
- 20Median of the firm: 2
- Events of the firm on the register
- 120
Other events of the firm
Official channels
- FDA enforcement report Z-1109-2023The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 91483. https://recallregister.com/fda/ii/91483/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide
- What quantity of product is in FDA event 91483?
- The event has 20 product records. The first record gives this quantity:
120 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2022 have the same class?
- 88% of the 839 device events that started in 2022 are in Class II.